Anesthetic Considerations for the Transcatheter Management of Mitral Valve Disease.

The development of transcatheter interventions to provide a minimally invasive alternative to open surgical repair has revolutionized the care of patients with valvular heart disease. Recently, this technology has been expanded to allow for the treatment of pathology of the mitral valve. This review discusses the anesthetic considerations for patients presenting for transcatheter management of mitral valve disease, including transcatheter mitral valve replacement (TMVR) and transcatheter mitral valve repair (TMVRep). The initial focus is on the current literature on transcatheter interventions for mitral valve pathologies as well as current and developing technology for TMVR and TMVRep. The authors' institutional experience with anesthetic management for the TMVR and TMVRep procedures is described, including potential pitfalls and complications, concluding with a discussion of the role of transesophageal echocardiography in the care of this patient population.

Treatment of Higher-Risk Patients With an Indication for Revascularization: Evolution Within the Field of Contemporary Percutaneous Coronary Intervention.

Patients with severe coronary artery disease with a clinical indication for revascularization but who are at high procedural risk because of patient comorbidities, complexity of coronary anatomy, and/or poor hemodynamics represent an understudied and potentially underserved patient population. Through advances in percutaneous interventional techniques and technologies and improvements in patient selection, current percutaneous coronary intervention may allow appropriate patients to benefit safely from revascularization procedures that might not have been offered in the past. The burgeoning interest in these procedures in some respects reflects an evolutionary step within the field of percutaneous coronary intervention. However, because of the clinical complexity of many of these patients and procedures, it is critical to develop dedicated specialists within interventional cardiology who are trained with the cognitive and technical skills to select these patients appropriately and to perform these procedures safely. Preprocedural issues such as multidisciplinary risk and treatment assessments are highly relevant to the successful treatment of these patients, and knowledge gaps and future directions to improve outcomes in this emerging area are discussed. Ultimately, an evolution of contemporary interventional cardiology is necessary to treat the increasingly higher-risk patients with whom we are confronted.

No reflow leading to catastrophic hemodynamic collapse in a patient with severe aortic stenosis and its management.

We report a case of an 87-year-old female who underwent percutaneous coronary intervention (PCI) for non-ST elevation myocardial infarction while she was being worked up for transcatheter aortic valve procedure. Hemodynamic compromise occurred during the PCI, which could only be mitigated by doing a balloon aortic valvuloplasty and Impella™ insertion. This case report will help in preparedness for any untoward events in patients with aortic stenosis and undergoing percutaneous coronary intervention.

Impact of intravascular ultrasound on the long-term clinical outcomes in the treatment of coronary ostial lesions.

OBJECTIVES: To evaluate the long-term outcomes of patients with ostial lesions who underwent percutaneous coronary intervention (PCI) with and without the use of intravascular ultrasound (IVUS). BACKGROUND: A higher rate of adverse cardiac events is associated with PCI of ostial lesions as compared with nonostial disease. METHODS: From 7/2002 to 8/2010, 225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance. Ostial lesions included both native aorto-ostial or major coronary vessel (left anterior descending, left circumflex, and ramus intermedius) lesions. Clinical outcomes [cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR)] at a mean follow-up of 4.2 ± 2.5 years were compared between patients undergoing PCI of an ostial lesion with and without use of IVUS using univariate and propensity score adjusted analyses. RESULTS: Aorto-ostial lesions (n = 109) comprised 47% of lesions, whereas the remaining lesions (53%) involved major coronary vessels. After propensity score adjustment, IVUS use was associated with lower rates of the composite of cardiovascular death, MI, or TLR (HR 0.54, 95% CI 0.29-0.99; P = 0.04), composite MI or TLR (HR 0.39, 95% CI 0.18-0.83; P = 0.01), and MI (HR 0.31, 95% CI 0.11-0.85; P = 0.02) as compared with no IVUS. The use of IVUS was also associated with a trend towards a lower rate of TLR (HR 0.42, 95% CI 0.17-1.02; P = 0.06). CONCLUSIONS: PCI of coronary ostial lesions with the use of IVUS was associated with significantly lower rates of adverse cardiac events.

Risk model for estimating the 1-year risk of deferred lesion intervention following deferred revascularization after fractional flow reserve assessment.

AIMS: Although lesions deferred revascularization following fractional flow reserve (FFR) assessment have a low risk of adverse cardiac events, variability in risk for deferred lesion intervention (DLI) has not been previously evaluated. The aim of this study was to develop a prediction model to estimate 1-year risk of DLI for coronary lesions where revascularization was not performed following FFR assessment. METHODS AND RESULTS: A prediction model for DLI was developed from a cohort of 721 patients with 882 coronary lesions where revascularization was deferred based on FFR between 10/2002 and 7/2010. Deferred lesion intervention was defined as any revascularization of a lesion previously deferred following FFR. The final DLI model was developed using stepwise Cox regression and validated using bootstrapping techniques. An algorithm was constructed to predict the 1-year risk of DLI. During a mean (±SD) follow-up period of 4.0 ± 2.3 years, 18% of lesions deferred after FFR underwent DLI; the 1-year incidence of DLI was 5.3%, while the predicted risk of DLI varied from 1 to 40%. The final Cox model included the FFR value, age, current or former smoking, history of coronary artery disease (CAD) or prior percutaneous coronary intervention, multi-vessel CAD, and serum creatinine. The c statistic for the DLI prediction model was 0.66 (95% confidence interval, CI: 0.61-0.70). CONCLUSION: Patients deferred revascularization based on FFR have variation in their risk for DLI. A clinical prediction model consisting of five clinical variables and the FFR value can help predict the risk of DLI in the first year following FFR assessment.

Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis: results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B).

BACKGROUND: In patients with severe aortic stenosis who cannot have surgery, transcatheter aortic valve replacement (TAVR) has been shown to improve survival and quality of life compared with standard therapy, but the costs and cost-effectiveness of this strategy are not yet known. METHODS AND RESULTS: The PARTNER trial randomized patients with symptomatic, severe aortic stenosis who were not candidates for surgery to TAVR (n=179) or standard therapy (n=179). Empirical data regarding survival, quality of life, medical resource use, and hospital costs were collected during the trial and used to project life expectancy, quality-adjusted life expectancy, and lifetime medical care costs to estimate the incremental cost-effectiveness of TAVR from a US perspective. For patients treated with TAVR, mean costs for the initial procedure and hospitalization were $42 806 and $78 542, respectively. Follow-up costs through 12 months were lower with TAVR ($29 289 versus $53 621) because of reduced hospitalization rates, but cumulative 1-year costs remained higher ($106 076 versus $53 621). We projected that over a patient's lifetime, TAVR would increase discounted life expectancy by 1.6 years (1.3 quality-adjusted life-years) at an incremental cost of $79 837. The incremental cost-effectiveness ratio for TAVR was thus estimated at $50 200 per year of life gained or $61 889 per quality-adjusted life-year gained. These results were stable across a broad range of uncertainty and sensitivity analyses. CONCLUSIONS: For patients with severe aortic stenosis who are not candidates for surgery, TAVR increases life expectancy at an incremental cost per life-year gained well within accepted values for commonly used cardiovascular technologies. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions.

OBJECTIVES: To assess the long-term clinical outcomes associated with treatment of nonleft main coronary bifurcation lesions using a modified provisional jailed-balloon technique (JBT). BACKGROUND: Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with a higher risk of adverse events, including the risk of side branch (SB) loss during main branch (MB) stenting. METHODS: From 4/2003 to 8/2010, 406 patients with 424 nonleft main coronary bifurcation lesions underwent PCI with (n = 95) and without (n = 311) the use of JBT. Rates of SB loss and long term clinical outcomes [death, myocardial infarction (MI), and target lesion revascularization (TLR)] were compared between patients undergoing PCI with and without JBT using univariate and propensity score adjusted and matched analyses. RESULTS: The majority of patients presented with acute coronary syndrome (63%) and 90% of lesions were Medina class 1,1,1. Patients were followed for a mean of 2.7 ± 2.1 years. After propensity score matching (n = 81 in each group), JBT was associated with a significantly lower composite rate of death, MI, or TLR (HR 0.22, 95% CI 0.06-0.76; P = 0.02) and TLR (HR 0.20, 95% 0.04-0.92; P = 0.04) compared with no JBT. Permanent SB loss was significantly lower in the JBT group compared with no JBT group (OR 0.22, 95% CI 0.10-0.49; P = 0.0001). CONCLUSIONS: The use of JBT for the treatment of nonleft main coronary bifurcation lesions was associated with significantly lower rates of SB loss and major adverse cardiac events at late follow-up.

A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique".

OBJECTIVES: To demonstrate the application of a novel provisional side branch (SB) stenting strategy for coronary bifurcation lesions using a "jailed-balloon" technique (JBT). BACKGROUND: Adverse cardiac events are higher for percutaneous coronary intervention (PCI) of bifurcation lesions. Recent studies support the use of provisional SB stenting, but a risk of SB closure and a higher rate of target lesion revascularization (TLR) remain important limitations. METHODS: From December 2007 to August 2010, 100 patients with 102 bifurcation lesions underwent PCI using the JBT. Baseline and postprocedural quantitative coronary angiography (QCA) analysis were performed. Procedural and immediate clinical outcomes were reviewed. RESULTS: The majority of patients presented with acute coronary syndrome (68%) and had Medina class 1,1,1 bifurcation lesions (91%). TIMI 3 flow was established in 100% of main branch and 99% of SB lesions. QCA revealed preservation of the bifurcation angle after PCI (pre-PCI: 59.6 ± 30.0; post-PCI: 63.3 ± 26.8, P = 0.41). Nine patients (9%) had lesions that required rewiring and two patients (2%) required provisional stenting of the SB. SB loss occurred in one patient (1%). The jailed-balloon or wire was not entrapped during any PCI. One patient (1%) suffered a periprocedural myocardial infarction (MI). CONCLUSIONS: Provisional stenting of complex coronary bifurcation lesions using a JBT is associated with a high procedural success rate, improved SB patency, and a low rate of immediate cardiac events. Further study is warranted to evaluate the role of JBT in improving long-term clinical outcomes in PCI of complex bifurcation lesions.

Defect closure in the lipomatous hypertrophied atrial septum with the Amplatzer muscular ventricular septal defect closure device: a case series.

Variations in the anatomy of the atrial septum can confound the transcatheter closure of atrial septal defects and patent foramen ovale. While lipomatous hypertrophy of the atrial septum is not frequently encountered, attempts to use standard atrial septal occlusion devices in such patient can lead to malapposition and continued shunt. Some operators have suggested that atrial septal hypertrophy is a relative contraindication to transcatheter-based closure techniques. We present a novel technique exploiting the features of the Amplatzer muscular ventricular septal defect occluder to treat atrial septal defects in the setting of lipomatous hypertrophy of the atrial septum in two patients.

Two-Year outcomes after utilization of the TAXUS paclitaxel-eluting stent in bifurcations and multivessel stenting in the ARRIVE registries.

AIMS: Examine the incidence of clinical events after utilization of the TAXUS(®) Express(®) paclitaxel-eluting stent (PES) in multivessel and bifurcation coronary stenting in an unselected patient population. METHODS AND RESULTS: The ARRIVE Program compiled data on 7,492 patients receiving ≥1 TAXUS Express PES, including patients with multivessel stenting (MVS; n = 1,208) and bifurcation stenting (n = 575). Patients were enrolled at procedure start with no mandated inclusion/exclusion criteria; all cardiac events were monitored with independent adjudication of end-points. Compared to simple use (single vessel/single stent) patients undergoing native intervention (N = 2,698), MVS patients had significantly more baseline comorbidities. Both groups had higher 2-year rates of mortality (7.3%[MVS] and 7.5%[bifurcation] vs. 4.2%[simple-use], P < 0.001), myocardial infarction (5.5% and 4.6% vs. 2.2%, P < 0.001 and P = 0.002), target vessel revascularization (15.5% and 14.8% vs. 7.7%, P < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.3% and 4.4% vs. 1.4%, P < 0.001) than the simple-use group. CONCLUSIONS: ARRIVE multivessel and bifurcation stenting patients have significantly higher clinical risk through 2 years compared to simple-use patients. In the absence of large randomized controlled trials in these populations, ARRIVE provides important insight into clinical outcomes over an extended period of time. (J Interven Cardiol 2011;24:342-350).

Two-year clinical outcomes with paclitaxel-eluting coronary stents in patients with chronic total occlusions: analysis from the TAXUS ARRIVE program.

AIMS: To examine the incidence of clinical events after implantation of the TAXUS Express paclitaxel-eluting stent (PES) in chronic total occlusions (CTO) in an unselected patient population. METHODS AND RESULTS: The TAXUS ARRIVE registries compiled data on 7,492 patients, including 113 patients with CTO (TIMI flow 0). Patients enrolled at procedure start with no mandated inclusion/exclusion criteria; all cardiac events were monitored with independent end-point adjudication. Two-year follow-up was 89% (101/113) for CTO patients who had significantly more baseline comorbidities/complex disease than simple-use patients undergoing native coronary intervention (N = 2,698) and significantly longer lesions/smaller vessels than other expanded-use patients (N = 4,681 without CTO). Among CTO patients the rate of 2-year major cardiac events (MCE, including cardiac death, myocardial infarction, and target vessel revascularization) was 22.3%, significantly higher than in simple-use patients (10.3%, P < 0.001). CTO MCE was similar to that for other expanded-use patients (16.5%, P = 0.14) but target lesion revascularization was significantly higher in year 2 (6.9% vs. 2.7%, P = 0.02). Academic Research Consortium definite/probable stent thrombosis through 2 years was 5.7%, significantly higher than simple-use patients but similar to other expanded-use cases. CONCLUSION: In a "real-world" setting, PES use in CTO was associated with increased MCE compared to simple- use patients, but achieved long-term outcomes similar to that observed in other complex patient/lesion cases.

Use of mechanical assist during high-risk PCI and STEMI with cardiogenic shock.

Infarct size may be reduced by left ventricular unloading after ST-segment elevation MI (STEMI) in addition to reperfusion therapy. Likewise, high-risk percutaneous coronary intervention (PCI) may benefit from periprocedural support especially in patients with low cardiac output at baseline or when periprocedural hemodynamic deterioration is anticipated. Traditionally, intraaortic balloon-pumps have been used in acute MI with cardiogenic shock. As this modality has limited hemodynamic benefits, new developments have focused on active hemodynamic assist devices. These devices actively unload the left ventricle increasing cardiac output by 2.5-5 L/min and are increasingly easier to implant and monitor. Thus, interventional cardiologists will be able to offer a safer more effective alternative to an increasing patient population with complex cardiac conditions and high-risk PCI.

Evidence based management of patients undergoing PCI. Conclusion.

A panel of leaders in the field of interventional cardiology convened to discuss the evidence-based management of patients undergoing percutaneous coronary intervention (PCI). The articles in this supplement are based on individual presentations given during the panel meeting. Following are key points of the panel's discussion and areas that the panel has indicated warrant further study.

Observed to expected 30-day mortality as a benchmark for transcatheter aortic valve replacement.

OBJECTIVE: The observed-to-expected 30-day mortality ratio (O:E ratio) is a standard metric by which transcatheter aortic valve replacement (TAVR) trials have been evaluated. Early TAVR trials consistently demonstrated O:E ratio less than 0.6 after TAVR when based on the Society for Thoracic Surgery Predicted Risk of Mortality (STS-PROM) for surgical aortic valve replacement. Recent published results from the Transcatheter Valve Therapy (TVT) Registry have demonstrated O:E ratios of 1.0. We evaluated our own O:E ratios for TAVR to investigate this discordance. METHODS: Data were collected prospectively for TAVR patients from 2008 through 2015 (N = 546) and were reviewed retrospectively. The observed mortality and STS-PROM were calculated to formulate O:E ratios and were compared over a variety of subgroups. RESULTS: Overall, the O:E ratio for 30-day mortality was 0.4 and significantly less than 1 (P < .001; 95% confidence interval, 0.25-0.63). The O:E ratio relationship remained less than 0.5 for patients with low (STS-PROM < 4), moderate (STS-PROM = 4-8) and high risk (STS-PROM > 8). The O:E ratio was significantly higher for transapical patients (O:E ratio = 0.8) when compared with transfemoral patients (O:E ratio = 0.2). Lastly, O:E ratios for both commercial (O:E ratio = 0.5) and research (O:E ratio = 0.3) patients were similar (P = .337), and both were significantly less than 1 (P = .007 and P < .001, respectively). CONCLUSIONS: The STS-PROM consistently overestimated 30-day mortality after TAVR. Achieving an O:E ratio less than 0.6 may be a realistic goal for all TAVR programs. While an accurate and specific risk calculator for 30-day mortality after TAVR remains to be established, our data suggest that current TVT results are not acceptable for commercial TAVR and that programs with an O:E ratio greater than 0.6, based on the STS-PROM, should reevaluate internal processes to improve their results.

Five-year outcomes of transcatheter reduction of significant mitral regurgitation in high-surgical-risk patients.

OBJECTIVES: This study evaluates the 5-year clinical outcomes of transcatheter mitral valve (MV) repair with the MitraClip device in patients at high risk for MV surgery treated in the Endovascular Valve Edge-to-Edge Repair (EVEREST) II High Risk Study (HRS). METHODS: Patients with mitral regurgitation (MR) 3+ or 4+ and predicted surgical mortality risk ≥12% or surgeon assessment based on prespecified high-risk factors were enrolled. Patients prospectively consented to 5 years of follow-up. RESULTS: At 5 years, clinical follow-up was achieved in 90% of 78 enrolled patients. The rate of postprocedural adverse events declined from 30 days to 1 year follow-up and was stable thereafter through 5 years. Two patients (2.6%) developed mitral stenosis (MS). Two patients underwent MV surgery, including one due to MS. A total of 42 deaths were reported through 5 years. Effectiveness measures at 5 years showed reductions in MR severity to ≤2+ in 75% of patients (p=0.0107), left ventricular (LV) end-diastolic volume (-38.2 mL; 95% CI -55.0 to -21.4; p<0.0001) and LV end-systolic volume (-14.6 mL; 95% CI -27.7 to -1.5; p=0.0303) compared with baseline. The New York Heart Association (NYHA) functional class improved from baseline to 5 years (p<0.005), and septal-lateral annular dimensions remained stable with no indication of mitral annular dilation through 5 years. CONCLUSIONS: The EVEREST II HRS demonstrated long-term safety and efficacy of MitraClip in high-surgical-risk patients through 5 years. The observed mortality was most likely a consequence of the advanced age and comorbidity profile of the enrolled patients, while improvements in NYHA class in surviving patients were durable through long-term follow-up. TRIAL REGISTRATION NUMBER: NCT01940120.

A clinical risk score for prediction of stent thrombosis.

The aim was to develop a clinically useful patient risk score predictive for stent thrombosis (ST). Using readily available baseline clinical and angiographic characteristics, a Cox proportional hazards multivariate model was used to identify significant (p <0.10) predictors of ST through 1 year in 2,487 patients receiving a TAXUS Express (Boston Scientific Corp., Natick, Massachusetts) drug-eluting stent (DES) in the ARRIVE 1 registry. Hazard ratios of significant predictors were rounded to an integer value ranging from 2 to 5. These values were summed for a maximum possible score of 24. The model was validated using 1-year data from a similar DES data set (ARRIVE 2, n = 4,820 patients). The 8 significant predictors found were thienopyridine therapy discontinuation before 6 months, insulin-requiring diabetes, smoker at baseline, left main stent placement, multiple stent placement, lesion length >28 mm, moderate to severe lesion calcification, and reference vessel diameter <3 mm. Model discrimination was high, indicated by an area under the receiver-operator characteristic curve of 0.819. Stratification of patients into low-, medium-, and high-risk groups showed that ST developed in 0.8% of patients with a score <6, 3.6% of patients with a score of 7 to 13, and 12.6% of patients with a score >or=14. In conclusion, using 8 readily available clinical and angiographic characteristics, we defined an ST risk score for patients receiving a DES during the first year. Analysis of patients from ARRIVE 1 and 2 showed that most (73%) were in the lowest risk category, with 25% in the moderate risk category. Less than 2% were at highest risk of developing ST.

Usage patterns and 2-year outcomes with the TAXUS express stent: results of the US ARRIVE 1 registry.

BACKGROUND: It is unclear how well the long-term safety and effectiveness of drug-eluting stents observed in tightly defined randomized controlled trials (RCT) translates to expanded use in routine practice. METHODS: The FDA-mandated TAXUS Express(2) ARRIVE 1 postmarket registry was designed to consecutively enroll patients receiving > or = 1 TAXUS stent in low-, medium-, and high-volume US sites (n = 50). All cardiac events plus an additional 20% sample of records were monitored and all endpoints were independently adjudicated. RESULTS: Detailed follow-up data through 2 years were compiled for 2,487 patients (95%). Simple-use (on-label) ARRIVE 1 patients (35%) had outcomes similar to 4 pooled TAXUS RCTs for death (3.5% vs. 3.4%, respectively, P = 0.78), Q-wave myocardial infarction (QWMI, 0.7% vs. 0.9%, P = 0.72), and stent thrombosis (ST, 2.2% vs. 1.2%, P = 0.12), but lower target vessel revascularization (7.8% vs. 13.4%, P < 0.0001). Compared with simple-use, cases representing expanded use to treat broader patient/lesion characteristics showed higher 2-year rates for death (7.4% vs. 3.5%, respectively, P = 0.0003), target lesion revascularization (9.4% vs. 5.8%, P = 0.0031), and ST (3.4% vs. 2.2%, P = 0.061, concentrated early in the first year). CONCLUSIONS: By including methods usually found in RCT, ARRIVE 1 captured a broad spectrum of disease treated in standard practice with high levels of ascertainment of clinical outcomes. In the more complicated cases, expectedly higher adverse event rates were seen compared to that found in the simple-use cases or pivotal RCT. These results have now been included in the Directions for Use, to aid in physician and patient decision-making.

Acute right ventricular failure and pulseless electrical activity arrest following auto-transfusion of blood.

Air embolism is a rare but potentially catastrophic complication of interventional procedures. The occurrence of acute right ventricular dysfunction during intraoperative auto-transfusion of blood, presumably related to pulmonary embolism of agitated air microbubbles and microthrombi, is less commonly recognized. We report a case of auto-transfusion complicated by acute right ventricular failure and pulseless electrical activity arrest. Auto-transfusion of recovered blood is a practical solution to reduce need for post-procedure allogenic transfusions. Although such interventions are frequently performed without complications, they do have inherent risks that should be readily acknowledged. This case clearly describes a severe complication and sequelae of auto-transfusion. .

Reversing the "Risk-Treatment Paradox" of Bleeding in Patients Undergoing Percutaneous Coronary Intervention: Risk-Concordant Use of Bleeding Avoidance Strategies Is Associated With Reduced Bleeding and Lower Costs.

Background Bleeding is a common, morbid, and costly complication of percutaneous coronary intervention. While bleeding avoidance strategies ( BAS ) are effective, they are used paradoxically less in patients at high risk of bleeding. Whether a patient-centered approach to specifically increase the risk-concordant use of BAS and, thus, reverse the risk-treatment paradox is associated with reduced bleeding and costs is unknown. Methods and Results We implemented an intervention to reverse the bleeding risk-treatment paradox at Barnes-Jewish Hospital, St. Louis, MO, and examined: (1) the temporal trends in BAS use and (2) the association of risk-concordant BAS use with bleeding and hospital costs of percutaneous coronary intervention. Among 3519 percutaneous coronary interventions, there was a significantly increasing trend ( P=0.002) in risk-concordant use of BAS . The bleeding incidence was 2% in the risk-concordant group versus 9% in the risk-discordant group (absolute risk difference, 7%; number needed to treat, 14). Risk-concordant BAS use was associated with a 67% (95% confidence interval, 52-78%; P<0.001) reduction in the risk of bleeding and a $4738 (95% confidence interval, 3353-6122; P<0.001) reduction in per-patient percutaneous coronary intervention hospitalization costs (21.6% cost-savings). Conclusions In this study, patient-centered care directly aimed to make treatment-related decisions based on predicted risk of bleeding, led to more risk-concordant use of BAS and reversal of the risk-treatment paradox. This, in turn, was associated with a reduction in bleeding and hospitalization costs. Larger multicentered studies are needed to corroborate these results. As clinical medicine moves toward personalization, both patients and hospitals can benefit from a simple practice change that encourages objectivity and mitigates variability in care.

Outcomes After the MitraClip Procedure in Patients at Very High Risk for Conventional Mitral Valve Surgery.

OBJECTIVE: Approximately 50% of patients with severe symptomatic mitral regurgitation are deemed too high risk for surgery. The MitraClip procedure is a viable option for this population. Our goal was to assess outcomes and survival of patients who underwent the MitraClip procedure at an institution where mitral valve surgery is routinely performed. METHODS: A retrospective study of patients undergoing the MitraClip procedure was performed. Baseline characteristics, perioperative outcomes, and follow-up echocardiographic and clinical outcomes were examined. Primary end point was survival. Secondary end points included technical failure (residual 3/4+ mitral regurgitation), reoperation, New York Heart Association symptoms, 30-day mortality, and other clinical outcomes. Predictors of mortality were determined using multivariable regression analysis. RESULTS: Fifty consecutive patients underwent the MitraClip procedure during the 4-year period. The average age was 83, the Society of Thoracic Surgeons predicted risk of mortality mean was 9.4%, 88% (44/50) had New York Heart Association III/IV symptoms, 86% (43/50) had 4+ mitral regurgitation, and 72% (36/50) had degenerative mitral disease etiology. Echocardiographic data (median [interquartile range] follow-up = 43 [26-392]) showed that 86% (43/50) of patients had 2+ or less mitral regurgitation. Sixty percent (24/40) had New York Heart Association I/II symptoms at last follow-up. Predictors of mortality were higher Society of Thoracic Surgeons predicted risk of mortality (P = 0.042, hazard ratio = 1.098) and previous cardiac surgery (P = 0.013, hazard ratio = 3.848). Survival at 1 and 2 years was 75% and 63%, respectively. CONCLUSIONS: Many patients with mitral valve regurgitation who are high risk for open surgery can be treated with the MitraClip procedure. In our study, most patients (86%) had a technically successful operation and postoperative outcomes including survival were acceptable.