Late survival and heart failure after transcatheter aortic valve implantation.

BACKGROUND: Short-term survival in patients undergoing transcatheter aortic valve implantation is favorable. Our aim was to evaluate late survival and composite clinical endpoints specified by the Valve Academic Research Consortium-2, including rehospitalization for congestive heart failure. METHODS: Between January 2008 and April 2014, 166 consecutive patients with severe symptomatic aortic stenosis underwent 168 transcatheter aortic valve implantation procedures at our facility. This cohort was compared with propensity score-matched aortic valve replacement patients. Event rates were estimated by the Kaplan-Meier method and compared using the log-rank test. Cox regression analysis was performed to determine predictors of outcome. RESULTS: Although 30-day mortality rates following both procedures were similar (4.2% and 4.8%; p = 0.81), significant differences were seen in corresponding rates of survival (51.7% ± 5.8% vs. 72.3% ± 4.3%; p < 0.001) and cumulative rehospitalization for congestive heart failure (41.3% ± 7.2% vs. 23% ± 4.3%; p = 0.006). New York Heart Association functional class IV preoperative status was an independent risk factor for rehospitalization due to congestive heart failure (p = 0.015). CONCLUSIONS: This study confirms the merit of transcatheter aortic valve implantation in high-risk patients with aortic stenosis, although late survival proved inferior to that of aortic valve replacement in propensity score-matched subjects. Early safety was excellent for both treatment groups, however, patients undergoing transcatheter aortic valve implantation had a higher incidence of rehospitalization for congestive heart failure and myocardial infarction during follow-up. Patients with severe congestive heart failure should be carefully monitored and aggressively treated to improve outcomes.

Acute kidney injury assessed by cystatin C after transcatheter aortic valve implantation and late renal dysfunction.

OBJECTIVE: The aim of the present study was to evaluate acute kidney injury (AKI) with cystatin C following transcatheter aortic valve implantation (TAVI) and to assess the impact of postoperative AKI on outcome and late renal function. DESIGN: A prospective study. SETTING: Single, tertiary referral center. PARTICIPANTS: Sixty-eight consecutive patients with severe aortic stenosis and advanced comorbidity. INTERVENTIONS: Blood samples were collected on 4 occasions pre- and postoperatively to determine levels of s-creatinine and cystatin C. Additionally, a sample was collected at followup 12 months postoperatively for the determination of s-creatinine. MEASUREMENTS AND MAIN RESULTS: The mean preoperative eGFR (s-creatinine) was 67±24 mL/min/1.73 m² compared to 45±21 mL/min/1.73 m² with eGFR (cystatin C) (p<0.001). Postoperative AKI was diagnosed in 25 patients (39%) with eGFR (cystatin C), compared to 21 patients (33%) with GFR (s-creatinine) and the RIFLE criteria. The 90-day mortality was 14.3% for the AKI+group and 2.3% for the AKI-group (p = 0.099). At 12 months followup, renal function remained impaired in patients with postoperative AKI and deteriorated in patients without. CONCLUSIONS: The risk of postoperative AKI is considerable following TAVI, with an increased risk of early mortality for AKI+patients. Cystatin C may be a valuable adjunct to the established biomarker s-creatinine for preoperative risk assessment and for early postoperative diagnosis of AKI. The acute postoperative renal impairment in patients with AKI does not fully recover in the long term. There is a progressive renal impairment in both groups postoperatively, the etiology probably being multifactorial.

Prediction of 30-day mortality after transcatheter aortic valve implantation: a comparison of logistic EuroSCORE, STS score, and EuroSCORE II.

BACKGROUND AND AIM OF THE STUDY: The logistic EuroSCORE and STS score have been used for the selection of suitable TAVI patients, but their predictive ability is unsatisfactory. The study aim was to evaluate the performance of the EuroSCORE II in predicting 30-day mortality after TAVI in comparison to the logistic EuroSCORE and STS scoring systems. METHODS: Between January 2008 and April 2013, a total of 123 consecutive patients underwent TAVI (transapical, n = 85; transfemoral, n = 38) at the authors' institution. Calibration and discriminatory ability was evaluated for three risk scores models (logistic EuroSCORE, STS score, and EuroSCORE II), and compared for the prediction of 30-day mortality using the Hosmer-Lemeshow test for goodness-of-fit and receiver operating characteristics curve analysis. RESULTS: The overall 30-day mortality was 4.1% (5/123). Predicted mortality was 25.0 ± 15.7% by logistic EuroSCORE, 7.3 ± 6.9% by STS score, and 7.8 ± 8.7% by EuroSCORE II. The observed/expected mortality ratio was 0.16 for logistic EuroSCORE, 0.56 for STS score, and 0.52 for EuroSCORE II. The area under the curve was 0.69 (95% CI 0.54-0.84) for the logistic EuroSCORE, 0.60 (95% CI 0.38-0.82) for the STS score, and 0.66 (95% CI 0.46-0.86) for the EuroSCORE II. CONCLUSION: In the present study, the EuroSCORE II was found to predict 30-day mortality more accurately for the TAVI cohort than did the more established logistic EuroSCORE, and also to compare (at present) on a par with the STS score. However, there were no differences in discriminatory power between the models. It is believed that, in the absence of a more TAVI-oriented risk stratification system, the EuroSCORE II may be a valuable adjunct in the clinical setting.

Functional and pharmacological characteristics of permeability transition in isolated human heart mitochondria.

The objective of the present study was to validate the presence and explore the characteristics of mitochondrial permeability transition (mPT) in isolated mitochondria from human heart tissue in order to investigate if previous findings in animal models of cardiac disorders are translatable to human disease. Mitochondria were rapidly isolated from fresh atrial tissue samples obtained from 14 patients undergoing Maze surgery due to atrial fibrillation. Human heart mitochondria exhibited typical mPT characteristics upon calcium overload such as swelling, evaluated by changes in light scattering, inhibition of respiration and loss of respiratory coupling. Swelling was a morphologically reversible event following transient calcium challenge. Calcium retention capacity (CRC), a quantitative measure of mPT sensitivity assayed by following extramitochondrial [Ca(2+)] and changes in respiration during a continuous calcium infusion, was significantly increased by cyclophilin D (CypD) inhibitors. The thiol-reactive oxidant phenylarsine oxide sensitized mitochondria to calcium-induced mPT. Release of the pro-apoptotic intermembrane protein cytochrome c was increased after, but not before, calcium discharge and respiratory inhibition in the CRC assay. From the present study, we conclude that adult viable heart mitochondria have a CypD- and oxidant-regulated mPT. The findings support that inhibition of mPT may be a relevant pharmacological target in human cardiac disease and may underlie the beneficial effect of cyclosporin A in reperfusion injury.

A Swedish consensus on the surgical treatment of concomitant atrial fibrillation.

Atrial fibrillation (AF) is a common arrhythmia among patients scheduled for open heart surgery and is associated with increased morbidity and mortality. According to international guidelines, symptomatic and selected asymptomatic patients should be offered concomitant surgical AF ablation in conjunction with valvular or coronary surgery. The gold standard in AF surgery is the Cox Maze III ("cut-and-sew") procedure, with surgical incisions in both atria according to a specified pattern, in order to prevent AF reentry circuits from developing. Over 90% of patients treated with the Cox Maze III procedure are free of AF after 1 year. Recent developments in ablation technology have introduced several energy sources capable of creating nonconducting atrial wall lesions. In addition, simplified lesion patterns have been suggested, but results with these techniques have been unsatisfactory. There is a clear need for standardization in AF surgery. The Swedish Arrhythmia Surgery Group, represented by surgeons from all Swedish units for cardiothoracic surgery, has therefore reached a consensus on surgical treatment of concomitant AF. This consensus emphasizes adherence to the lesion pattern in the Cox Maze III procedure and the use of biatrial lesions in nonparoxysmal AF.

Transapical versus transfemoral aortic valve implantation: a comparison of survival and safety.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a therapeutic option for high-risk patients with aortic stenosis. Procedural mortality remains high in comparison with conventional aortic valve replacement (AVR) because patients determined for TAVI are commonly denied conventional surgery. We aimed to evaluate access-related complications between the transfemoral (TF) and the transapical (TA) approach and to compare survival between TAVI and conventional AVR in propensity-score-matched patients. METHODS: Between January 2008 and November 2009, 40 patients underwent TAVI (TF, n=10; TA, n=30) with the Edwards Sapien bioprosthesis (Edwards Lifesciences, Irvine, CA). Survival and postoperative complications were evaluated between the TF and the TA approach. A comparison of survival was made between the TAVI patients and propensity-score-matched patients undergoing conventional AVR. RESULTS: Successful implantation rate was 92.5% (37 of 40). Thirty-day mortality was 5.0% (2 of 40), and the overall in-hospital mortality was 10.0% (4 of 40). Survival after TAVI was 77% at both 6 months and 1 year. Major vascular complications occurred in 3 of 10 patients (all in the TF group), and 3 of 40 patients (7.5%) suffered cerebrovascular events. A comparison of survival between TAVI and propensity score-matched conventional AVR patients showed no significant difference in either the TA group (p=0.73) or the TF group (p=0.59). CONCLUSIONS: The vascular complications occurring when using the TF approach were probably related to a combination of a wide introducer sheath and heavily calcified femoral arteries in a high-risk population. No serious complications were encountered when using the TA approach. After propensity-score matching, survival with both the TA and TF approaches is similar to that after AVR.

Increased expression of vascular endothelin type B and angiotensin type 1 receptors in patients with ischemic heart disease.

BACKGROUND: Endothelin-1 and angiotensin II are strong vasoconstrictors. Patients with ischemic heart disease have elevated plasma levels of endothelin-1 and angiotensin II and show increased vascular tone. The aim of the present study was to examine the endothelin and angiotensin II receptor expression in subcutaneous arteries from patients with different degrees of ischemic heart disease. METHODS: Subcutaneous arteries were obtained, by biopsy from the abdomen, from patients undergoing coronary artery bypass graft (CABG) surgery because of ischemic heart disease (n = 15), patients with angina pectoris without established myocardial infarction (n = 15) and matched cardiovascular healthy controls (n = 15). Endothelin type A (ETA) and type B (ETB), and angiotensin type 1 (AT1) and type 2 (AT2) receptors expression and function were examined using immunohistochemistry, Western blot and in vitro pharmacology. RESULTS: ETA and, to a lesser extent, ETB receptor staining was observed in the healthy vascular smooth muscle cells. The level of ETB receptor expression was higher in patients undergoing CABG surgery (250% +/- 23%; P < 0.05) and in the patients with angina pectoris (199% +/- 6%; P < 0.05), than in the healthy controls (100% +/- 28%). The data was confirmed by Western blotting. Arteries from CABG patients showed increased vasoconstriction upon administration of the selective ETB receptor agonist sarafotoxin S6c, compared to healthy controls (P < 0.05). No such difference was found for the ETA receptors. AT1 and, to a lesser extent, AT2 receptor immunostaining was seen in the vascular smooth muscle cells. The level of AT1 receptor expression was higher in both the angina pectoris (128% +/- 25%; P < 0.05) and in the CABG patients (203% +/- 41%; P < 0.05), as compared to the healthy controls (100% +/- 25%). The increased AT1 receptor expression was confirmed by Western blotting. Myograph experiment did however not show any change in vasoconstriction to angiotensin II in CABG patients compared to healthy controls (P = n.s). CONCLUSION: The results demonstrate, for the first time, upregulation of ETB and AT1 receptors in vascular smooth muscle cells in ischemic heart disease. These receptors may play a role in the pathophysiology of ischemic heart disease and could provide important targets for pharmaceutical interventions.

Moderate mitral regurgitation in patients undergoing CABG--the MoMIC trial.

BACKGROUND: The presence of mild to moderate ischemic mitral regurgitation (IMR) marks a significantly reduced long-term survival and increased hospitalizations due to heart-failure. However, it is common practice in many institutions to refrain from repairing the mitral valve in these patients. There are no available conclusive data to support this practice, and thus there is a need for an adequately powered randomized trial. STUDY DESIGN: The Moderate Mitral Regurgitation In Patients Undergoing CABG (MoMIC) trial is the first international multi-center, large-scale study to clarify whether moderate IMR in CABG patients should be corrected. A total of 550 CABG patients with moderate IMR are to be randomized to treatment of either CABG alone or CABG plus mitral valve correction. The primary end point is a composite end point of mortality and rehospitalization for heart failure at five years. The inclusion and randomization of patients started in February 2008. IMPLICATION: If correction of moderate IMR in CABG patients proves to be the superior strategy, most patients should be treated accordingly.

The prevalence of moderate mitral regurgitation in patients undergoing CABG.

OBJECTIVE: The aim of this study was to determine the prevalence of moderate ischemic mitral regurgitation (IMR) in the contemporary CABG population. We also aimed to correlate the effective regurgitant orifice area (ERO) of any regurgitant mitral valve in patients with coronary artery disease with the semiquantitative integrated scale of IMR. DESIGN: From March 15 through June 15, 2006, 510 consecutive CABG patients in three tertiary centres were included in the study. All patients showing any sign of mitral regurgitation (MR) at the referring hospital underwent a preoperative transthoracic echocardiographic estimation of the degree of MR using the integrated scale (1-4) and ERO. RESULTS: IMR was found in 141 patients (28%). The prevalence of moderate 2+ or worse IMR was 4% (95% CI; 2.5-6.1%) and the ERO corresponding to 2+ IMR or more ranged from 5 to 30 mm(2). Fourteen patients had an ERO between 15-30 mm(2). CONCLUSIONS: According to our study, patients with moderate IMR, defined as an ERO between 15-30 mm(2), account for only 2.7% (95% CI; 1.5-4.7%) of a non-emergency CABG population.

Percutaneous transvenous mitral annuloplasty: initial human experience with device implantation in the coronary sinus.

BACKGROUND: Mitral annuloplasty is the most common surgical procedure performed for ischemic mitral regurgitation (MR). Surgical mitral annuloplasty is limited by morbidity, mortality, and MR recurrence. We evaluated the safety and feasibility of a transvenous catheter-delivered implantable device to provide a percutaneous alternative to surgical mitral annuloplasty. METHODS AND RESULTS: Five patients with chronic ischemic MR underwent percutaneous transvenous implantation of an annuloplasty device in the coronary sinus. Implantation was successful in 4 patients. Baseline MR in the entire group was grade 3.0+/-0.7 and was reduced to grade 1.6+/-1.1 at the last postimplantation visit when the device was intact or the last postprocedural visit in the patient in whom the device was not successfully implanted. Separation of the bridge section of the device occurred in 3 of 4 implanted devices and was detected at 28 to 81 days after implantation. There were no postprocedural device-related complications. CONCLUSIONS: Percutaneous implantation of a device intended to remodel the mitral annulus is feasible. Initial experience suggests a possible favorable effect on MR. Percutaneous transvenous mitral annuloplasty warrants further evaluation as a less invasive alternative to surgical annuloplasty.

Percutaneous treatment of ischaemic mitral regurgitation in sheep.

AIMS: A percutaneous mitral annuloplasty device for implantation in the coronary sinus was evaluated in surviving sheep with ischaemia-induced mitral regurgitation. METHODS AND RESULTS: Microspheres were injected in the left coronary artery of thirty-seven sheep. The treatment was repeated in one month intervals until the resulting myocardial infarctions caused significant mitral regurgitation. Fourteen animals developed a mitral regurgitation degree 2 or higher after 130+/-16 days and 3.4+/-0.4 treatments. The annuloplasty device was implanted percutaneously within the coronary sinus and the animals were followed 97+/-6 days (n=14) with monthly intracardiac echocardiograms. The MR grade (0-4) decreased from 3.1+/-0.2 at the time for implantation to 0.8+/-0.2 (p=0.0005) at the 3 month follow up. The vena contracta decreased from 6.5+/-0.4 mm to 2.0+/-0.7 mm after 3 months (p=0.0007). The mitral septo-lateral diameter was reduced after insertion of the device, from 38+/-1 mm before implantation to 35+/-1 mm after 3 months (P=0.0322). Angiography showed no signs of impairment of the coronary arteries. No thrombosis was observed. CONCLUSION: These results indicate that experimentally induced ischaemic mitral regurgitation can be significantly reduced by means of a percutaneous catheter technique from the coronary sinus in surviving sheep.

Percutaneous Transvenous Mitral Annuloplasty (PTMA) with the Viking device reduces pacing-induced mitral regurgitation.

OBJECTIVES: The new percutaneous mitral annuloplasty Viking device was evaluated in surviving sheep with pacing-induced mitral regurgitation. METHODS AND RESULTS: Twenty sheep were subjected to rapid ventricular pacing for one to three months, leading to cardiomyopathy and mitral regurgitation. Device implantation could be successfully performed in 11 of these animals after pacemaker treatment for 64+/-7 days. The device-related procedure time was 12+/-2 min. The mean follow-up time was 58+/-8 days after implantation of the device. Mitral annulus septo-lateral diameter was significantly reduced after insertion of the device, from 35+/-1 mm before implantation to 30+/-1 mm at the final follow up intracardiac echocardiography (P = 0.0097). The degree of mitral regurgitation (on a scale from 0 to 4) was 2.6+/-0.2 before device implantation and decreased to 0.8+/-0.2 after treatment (P = 0.0039), and the vena contracta was reduced from 7+/-0.4 mm to 3+/-0.8 mm (P = 0.0019). Angiography showed no signs of impairment of the coronary arteries. No thrombosis was observed. CONCLUSIONS: These results indicate that the septo-lateral diameter of the mitral annulus, and the degree of experimentally induced mitral regurgitation, can be significantly reduced with a percutaneous catheter technique in surviving sheep.

Patient reactions to cancelled or postponed heart operations.

OBJECTIVES: The aim was to survey the rate and cause of cancellations of planned cardiac operations at a Swedish clinic during 1999, and to study how the patients were affected. DESIGN: Questionnaires were distributed to 74 patients who had their operations cancelled. Their mood after discharge was measured with The Hospital Anxiety and Depression scale. Ninety-three patients, who were operated on without postponement, served as controls. RESULTS: Sixty-one percent of the patients in the cancellation group reacted negatively, especially if the reason for cancellation was organizational (P = 0.03). The women in the cancellation group had a significantly higher degree of depression than men (P = 0.01) and both women (P = 0.02) and men (P = 0.003) in the control group. Most of the patients, however, were satisfied with the nursing staff's reception and information. CONCLUSIONS: The patients reacted negatively to the cancellation, especially if it had organizational reasons. Women subjected to cancellation had a significantly higher degree of depression than other patients. To be avoided, organizational and medical problems must be identified in time. One way to do this is to introduce a preadmission nurse clinic.