Publications by authors named "Nicholas G Smedira"

172 Publications

Outcomes in Patients With Obstructive Hypertrophic Cardiomyopathy and Concomitant Aortic Stenosis Undergoing Surgical Myectomy and Aortic Valve Replacement.

J Am Heart Assoc 2021 Sep 17;10(18):e018435. Epub 2021 Sep 17.

Hypertrophic Cardiomyopathy and Valve Center Heart and Vascular Institute Cleveland Clinic Cleveland OH.

Background Hypertrophic cardiomyopathy (HCM) and aortic stenosis can cause obstruction to the flow of blood out of the left ventricular outflow tract into the aorta, with obstructive HCM resulting in dynamic left ventricular outflow tract obstruction and moderate or severe aortic stenosis causing fixed obstruction caused by calcific degeneration. We sought to report the characteristics and longer-term outcomes of patients with severe obstructive HCM who also had concomitant moderate or severe aortic stenosis requiring surgical myectomy and aortic valve replacement. Methods and Results We studied 191 consecutive patients (age 67±6 years, 52% men) who underwent myectomy and aortic valve (AV) replacement (90% bioprosthesis) at our center between June 2002 and June 2018. Clinical and echo data including left ventricular outflow tract gradient and indexed AV area were recorded. The primary outcome was death. Prevalence of hypertension (63%) and hyperlipidemia (75%) were high, with a Society of Thoracic Surgeons score of 5±4, and 70% of participants had no HCM-related sudden death risk factors. Basal septal thickness and indexed AV area were 1.9±0.4 cm and 0.72±0.2 cm/m, respectively, while 100% of patients had dynamic left ventricular outflow tract gradient >50 mm Hg. At 6.5±4 years, 52 (27%) patients died (1.5% in-hospital deaths). One-, 2-, and 5-year survival in the current study sample was 94%, 91%, and 83%, respectively, similar to an age-sex-matched general US population. On multivariate Cox survival analysis, age (hazard ratio [HR], 1.65; 95% CI, 1.24-2.18), chronic kidney disease (HR, 1.58; 95% CI, 1.21-2.32), and right ventricular systolic pressure on preoperative echocardiography (HR, 1.28; 95% CI, 1.05-1.57) were associated with longer-term mortality, but traditional HCM risk factors did not. Conclusions In symptomatic patients with severely obstructive HCM and moderate or severe aortic stenosis undergoing a combined surgical myectomy and AV replacement at our center, the observed postoperative mortality was significantly lower than the expected mortality, and the longer-term survival was similar to a normal age-sex-matched US population.
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http://dx.doi.org/10.1161/JAHA.120.018435DOI Listing
September 2021

Study design and rationale of VALOR-HCM: evaluation of mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathy who are eligible for septal reduction therapy.

Am Heart J 2021 09 24;239:80-89. Epub 2021 May 24.

Department of cardiovascular medicine, Heart and Vascular Institute, Cleveland CLinic, Cleveland OH; Cleveland Clinic Coordinating Center for Clinical Research, Heart and Vascular Institute, Cleveland CLinic, Cleveland OH.

Background: Hypertrophic cardiomyopathy (HCM) is a primary myocardial disorder which frequently leads to symptoms such as dyspnea and exercise intolerance, often due to severe dynamic left ventricular outflow tract obstruction (LVOTO). Current guideline-recommended pharmacotherapies have variable therapeutic responses to relieve LVOTO. In recent phases 2 and 3, clinical trials for symptomatic obstructive HCM (oHCM), mavacamten, a small molecule inhibitor of β-cardiac myosin has been shown to improve symptoms, exercise capacity, health status, reduce LVOTO, along with having a beneficial impact on cardiac structure and function.

Methods: VALOR-HCM is designed as a multicenter (approximately 20 centers in United States) phase 3, double-blind, placebo-controlled, randomized study. The study population consists of approximately 100 patients (≥18 years old) with symptomatic oHCM who meet 2011 American College of Cardiology/American Heart Association and/or 2014 European Society of Cardiology HCM-guideline criteria and are eligible and willing to undergo septal reduction therapy (SRT). The study duration will be up to 138 weeks, including an initial 2-week screening period, followed by16 weeks of placebo-controlled treatment, 16 weeks of active blinded treatment, 96 weeks of long-term extension, and an 8-week posttreatment follow-up visit. The primary endpoint will be a composite of the decision to proceed with SRT prior to or at Week 16 or remain guideline eligible for SRT at Week 16. Secondary efficacy endpoints will include change (from baseline to Week 16 in the mavacamten group vs placebo) in postexercise LVOT gradient, New York Heart Association class, Kansas City Cardiomyopathy Questionnaire clinical summary score, NT-proBNP, and cardiac troponin. Exploratory endpoints aim to characterize the effect of mavacamten on multiple aspects of oHCM pathophysiology.

Conclusions: In severely symptomatic drug-refractory oHCM patients meeting guideline criteria of eligibility for SRT, VALOR-HCM will primarily study if a 16-week course of mavacamten reduces or obviates the need for SRT using clinically driven endpoints.
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http://dx.doi.org/10.1016/j.ahj.2021.05.007DOI Listing
September 2021

Commentary: Is length (of the anterior mitral leaflet) important?

J Thorac Cardiovasc Surg 2021 Feb 3. Epub 2021 Feb 3.

Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2021.01.110DOI Listing
February 2021

Characteristics and Outcomes of Elderly Patients With Hypertrophic Cardiomyopathy.

J Am Heart Assoc 2021 02 28;10(3):e018527. Epub 2021 Jan 28.

Hypertrophic Cardiomyopathy Center Heart and Vascular InstituteCleveland Clinic Cleveland OH.

Background We report characteristics and outcomes of elderly patients with hypertrophic cardiomyopathy (HCM) with basal septal hypertrophy and dynamic left ventricular outflow tract obstruction. Methods and Results We studied 1110 consecutive elderly patients with HCM (excluding moderate or greater aortic stenosis or subaortic membrane, age 80±5 years [range, 75-92 years], 66% women), evaluated at our center between June 2002 and December 2018. Clinical and echocardiographic data, including maximal left ventricular outflow tract gradient, were recorded. The primary outcome was death and appropriate internal defibrillator discharge. Hypertension was observed in 72%, with a Society of Thoracic Surgeons (STS) score (8.6±6); while 80% had no HCM-related sudden cardiac death risk factors. Left ventricular mass index, basal septal thickness, and maximal left ventricular outflow tract gradient were 127±43 g/m, 1.7±0.4 cm, and 49±31 mm Hg, respectively. A total of 597 (54%) had a left ventricular outflow tract gradient >30 mm Hg, of which 195 (33%) underwent septal reduction therapy (SRT; 79% myectomy and 21% alcohol ablation). At 5.1±4 years, 556 (50%) had composite events (273 [53%] in nonobstructive, 220 [55%] in obstructive without SRT, and 63 [32%] in obstructive subgroup with SRT). One- and 5-year survival, respectively were 93% and 63% in nonobstructive, 90% and 63% in obstructive subgroup without SRT, and 94% and 84% in the obstructive subgroup with SRT. Following SRT, there were 5 (2.5%) in-hospital deaths (versus an expected Society of Thoracic Surgeons mortality of 9.2%). Conclusions Elderly patients with HCM have a high prevalence of traditional cardiovascular rather than HCM risk factors. Longer-term outcomes of the obstructive SRT subgroup were similar to a normal age-sex matched US population.
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http://dx.doi.org/10.1161/JAHA.120.018527DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955450PMC
February 2021

Impact of left atrial strain mechanics on exercise intolerance and need for septal reduction therapy in hypertrophic cardiomyopathy.

Eur Heart J Cardiovasc Imaging 2021 Jan 18. Epub 2021 Jan 18.

Section of Cardiovascular Imaging, Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA.

Aims: We sought to assess the relationship between left atrial (LA) strain mechanics and exercise intolerance, and to evaluate the prognostic impact of LA strain mechanics on clinical deterioration necessitating septal reduction therapy in hypertrophic cardiomyopathy (HCM).

Methods And Results: Consecutive HCM patients who underwent exercise stress echocardiography and cardiopulmonary exercise testing on the same day between October 2015 and April 2019 were enrolled prospectively. LA strain mechanics were analysed using speckle tracking echocardiography. LA stiffness was calculated as the ratio of E/e' ratio to LA reservoir strain. The study cohort was divided into four groups based on the quartile of percent-predicted peak VO2, and exercise intolerance was defined as the lowest quartile (≤51%). Of 532 patients studied (mean age: 51 ± 15 years, 42% female), 138 patients demonstrated exercise intolerance. As exercise capacity worsened, LA strain mechanics worsened along a continuum (P < 0.001). LA contractile strain with a cut-off of -13.9% was optimal at identifying exercise intolerance. On multivariable analysis, worse LA contractile strain was an independent predictor for exercise intolerance (P = 0.002). Of patients with left ventricular outflow tract obstruction, patients with LA stiffness worse than the median value (≥0.41) were significantly more likely to require septal reduction therapy than those with better LA stiffness (P = 0.026).

Conclusion: Worse LA contractile strain was an independent predictor for exercise intolerance in HCM. Patients with worse LA stiffness had a higher probability of clinical deterioration necessitating septal reduction therapy.
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http://dx.doi.org/10.1093/ehjci/jeab001DOI Listing
January 2021

Outcomes in Guideline-Based Class I Indication Versus Earlier Referral for Surgical Myectomy in Hypertrophic Obstructive Cardiomyopathy.

J Am Heart Assoc 2021 01 21;10(1):e016210. Epub 2020 Dec 21.

Hypertrophic Cardiomyopathy Center Heart and Vascular Institute Cleveland Clinic Cleveland OH.

Background In patients with obstructive hypertrophic cardiomyopathy, surgical myectomy (SM) is indicated for severe symptoms. We sought to compare long-term outcomes of patients with obstructive hypertrophic cardiomyopathy where SM was based on guideline-recommended Class I indication (Functional Class or FC ≥3 or angina/exertional syncope despite maximal medical therapy) versus earlier (FC 2 and/or impaired exercise capacity on exercise echocardiography with severe obstruction). Methods and Results We studied 2268 consecutive patients (excluding <18 years, ≥ moderate aortic stenosis and subaortic membrane, 56±14 years, 55% men), who underwent SM at our center between June 2002 and March 2018. Clinical data, including left ventricular outflow tract gradient, were recorded. Death and/or appropriate internal defibrillator discharge were primary composite end points. One thousand three hundred eighteen (58%) patients met Class I indication and 950 (42%) underwent earlier surgery; 222 (10%) had a history of obstructive coronary artery disease. Basal septal thickness, and resting and maximal left ventricular outflow tract gradient were 2.0±0.3 cm, 61±44 mm Hg, and 100±31 mm Hg, respectively. At 6.2±4 years after SM, 248 (11%) had composite events (13 [0.6%] in-hospital deaths). Age (hazard ratio [HR], 1.61; 95% CI, 1.26-1.91), obstructive coronary artery disease (HR, 1.46; 95% CI, 1.06-1.91), and Class I versus earlier SM (HR, 1.61; 95% CI, 1.14-2.12) were associated with higher primary composite events (all <0.001). Earlier surgery had better longer-term survival (similar to age-sex-matched normal population) versus surgery for Class I indication (76 [8%] versus 193 [15%], <0.001). Conclusions In patients with obstructive hypertrophic cardiomyopathy, earlier versus surgery for Class I indication had a better long-term survival, similar to the age-sex-matched US population.
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http://dx.doi.org/10.1161/JAHA.120.016210DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955478PMC
January 2021

Characteristics and Longer-Term Outcomes of Contemporary Patients <18 Years of Age With Hypertrophic Cardiomyopathy.

Am J Cardiol 2021 02 4;140:110-117. Epub 2020 Nov 4.

Hypertrophic Cardiomyopathy Center, Heart and Vascular Institute and Children's Hospital, Cleveland Clinic, Cleveland, Ohio. Electronic address:

We describe characteristics and outcomes of contemporary pediatric hypertrophic cardiomyopathy (PHC) patients. We studied 398 consecutive pediatric HC patients (<18 years, median 14 years, 65% boys) seen at our center between 2002 and 2018. Baseline clinical and pediatric echocardiographic data was collected. Left ventricular outflow tract gradient (LVOTG), LV fractional shortening and Z-score for left ventricular (LV) wall thickness were calculated. Sudden cardiac death (SCD), appropriate internal defibrillator discharge (ICD), myectomy, and orthotopic heart transplant (OHT) were composite primary endpoint. A total of 133 (33%) had symptoms (71 [18%] dyspnea, 77 [19%] angina, and 19 [5%] syncope), 109 (27%) were on beta-blockers; 179 (45%) had family history of HC. A total of 146 (37%) underwent genetic testing (of which 91 (62%) were HC-gene positive). Basal septal LV thickness, septal LV z-score and fractional shortening were 1.2 ± 0.6 cm, 4.8 ± 5.6, and 42% ± 8, whereas 23% had extreme LV hypertrophy (z-score > 6) and 8% had LVOTG >30 mm Hg (range 0 to 139 mm Hg). At a median of 5.9 years (interquartile range 2.4, 9), there were 23 (6%) ICD's placed, and 47 (12%) primary composite events (9 [2%] deaths, 3 [1%] appropriate ICD discharge, 29 [7%] myectomy, and 8 [2%] OHT). There were no in hospital deaths following myectomy/OHT. Presence of symptoms (Hazard ratio or HR 2.45), ventricular tachycardia (HR 1.52), and higher basal septal LV z-score (HR 1.10) were independently associated with primary composite outcomes. LV septal z-score >4 was independently associated with events on spline analysis. Rate of SCD/appropriate ICD discharge was 0.5%/year. In conclusion, contemporary PHC patients seen at an experienced center have excellent outcomes with presence of symptoms and higher LV septal thickness associated with primary composite events.
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http://dx.doi.org/10.1016/j.amjcard.2020.10.060DOI Listing
February 2021

Discussion.

J Thorac Cardiovasc Surg 2021 Mar 22;161(3):1005-1006. Epub 2020 Sep 22.

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http://dx.doi.org/10.1016/j.jtcvs.2020.08.111DOI Listing
March 2021

Robotic trans-mitral septal myectomy and papillary muscle reorientation for HOCM combined with or without mitral valve repair: Technical aspects - How we do it.

J Card Surg 2020 Nov 2;35(11):3120-3124. Epub 2020 Aug 2.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

Hypertrophic obstructive cardiomyopathy (HOCM) is one of the more common genetic disorders. The pathophysiology and natural history of the disease have been well studied. Left ventricular outflow tract obstruction (LVOTO) and systolic anterior motion (SAM) of the anterior mitral leaflet can result in sudden cardiac death, progressive heart failure and arrythmias. Surgical septal myectomy for HOCM is the standard of care and is routinely performed through a median sternotomy. Septal myectomy has also been performed using the trans-atrial, trans-mitral approach either directly or with robotic assistance. In cases with severe LVOT obstruction in the setting of only mild to moderate proximal septal hypertrophy, intrinsic problems with the mitral valve contribute. Typically, these are hypermobile papillary muscles and or excessive height of the anterior mitral leaflet. Combining septal myectomy with reorientation of hypermobile anteriorly positioned papillary muscles has shown to prevent SAM and thereby additionally decrease the subvalvular aortic outflow obstruction. Our extensive experience in both septal myectomy and robotic mitral valve repair has given us a different perspective in approaching the primary mitral regurgitation in HOCM patients where a combined septal myectomy, papillary muscle reorientation and complex mitral valve repair has been safely performed using the less invasive robotic-assisted approach.Our objective here is to discuss the technical aspects of the procedure.
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http://dx.doi.org/10.1111/jocs.14919DOI Listing
November 2020

Dynamic prediction of left ventricular assist device pump thrombosis based on lactate dehydrogenase trends.

ESC Heart Fail 2019 10 18;6(5):1005-1014. Epub 2019 Jul 18.

Department of Cardiovascular Medicine, Heart and Vascular Institute, Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, OH, USA.

Aims: The risk of HeartMate II (HMII) left ventricular assist device (LVAD) thrombosis has been reported, and serum lactate dehydrogenase (LDH), a biomarker of haemolysis, increases secondary to LVAD thrombosis. This study evaluated longitudinal measurements of LDH post-LVAD implantation, hypothesizing that LDH trends could timely predict future LVAD thrombosis.

Methods And Results: From October 2004 to October 2014, 350 HMIIs were implanted in 323 patients at Cleveland Clinic. Of these, patients on 339 HMIIs had at least one post-implant LDH value (7996 total measurements). A two-step joint model combining longitudinal biomarker data and pump thrombosis events was generated to assess the effect of changing LDH on thrombosis risk. Device-specific LDH trends were first smoothed using multivariate boosted trees, and then used as a time-varying covariate function in a multiphase hazard model to analyse time to thrombosis. Pre-implant variables associated with time-varying LDH values post-implant using boostmtree were also investigated. Standardized variable importance for each variable was estimated as the difference between model-based prediction error of LDH when the variable was randomly permuted and prediction error without permuting the values. The larger this difference, the more important a variable is for predicting the trajectory of post-implant LDH. Thirty-five HMIIs (10%) had either confirmed (18) or suspected (17) thrombosis, with 15 (43%) occurring within 3 months of implant. LDH was associated with thrombosis occurring both early and late after implant (P < 0.0001 for both hazard phases). The model demonstrated increased probability of HMII thrombosis as LDH trended upward, with steep changes in LDH trajectory paralleling trajectories in probability of pump thrombosis. The most important baseline variables predictive of the longitudinal pattern of LDH were higher bilirubin, higher pre-implant LDH, and older age. The effect of some pre-implant variables such as sodium on the post-implant LDH longitudinal pattern differed across time.

Conclusions: Longitudinal trends in surveillance LDH for patients on HMII support are useful for dynamic prediction of pump thrombosis, both early after implant and late. Incorporating upward and downward trends in LDH that dynamically update a model of LVAD thrombosis risk provides a useful tool for clinical management and decisions.
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http://dx.doi.org/10.1002/ehf2.12473DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6816063PMC
October 2019

Surgical management of left ventricular outflow tract obstruction in a specialized hypertrophic obstructive cardiomyopathy center.

J Thorac Cardiovasc Surg 2019 06 29;157(6):2289-2299. Epub 2018 Dec 29.

Departments of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objectives: This study evaluates operative approach and contemporary surgical outcomes in the management of left ventricular outflow tract obstruction by a single surgeon at a high-volume, specialized hypertrophic cardiomyopathy center.

Methods: This is a retrospective review of 1559 consecutive operations for left ventricular outflow tract obstruction from 2005 to 2015. Demographic profiles, echocardiogram-derived ventricular morphology and hemodynamics, operative data, and in-hospital outcomes were analyzed.

Results: Of the 1559 operations, 586 were isolated septal myectomies, 522 were myectomies with mitral valve or subvalvular apparatus intervention, 422 were myectomies with another concomitant procedure, and 29 were isolated mitral valve interventions without myectomy. Common mitral valve interventions included anterior leaflet shortening (16%), chordae tendineae resection (9.8%), papillary muscle resection (7.2%), and papillary muscle reorientation (7.5%). Ninety-two patients underwent mitral valve replacement, 42 for left ventricular outflow tract obstruction and 50 for intrinsic mitral valve pathology. Patients undergoing mitral interventions had thinner septums (18 ± 0.4 mm vs 22 ± 0.5 mm, P < .001) and less myocardium removed (6.2 ± 3.5 g vs 8.8 ± 3.8 g, P < .001) than patients without a mitral intervention. Prevalence of in-hospital permanent pacemaker insertion was 4.2% (n = 1334) for complete heart block and 1.1% (n = 464) for isolated septal myectomy with normal preoperative conduction. Overall, there were 2 postoperative ventricular septal defects (0.13%) and none for isolated myectomies. Operative mortality was 0.38%.

Conclusions: Septal myectomy can be performed safely with excellent outcomes when the procedure is performed by a highly experienced surgeon in a high-volume, specialized center. A mitral valve intervention is a useful adjunct in patients with moderate hypertrophy.
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http://dx.doi.org/10.1016/j.jtcvs.2018.11.148DOI Listing
June 2019

Advances in managing the noninfected open chest after cardiac surgery: Negative-pressure wound therapy.

J Thorac Cardiovasc Surg 2019 05 27;157(5):1891-1903.e9. Epub 2018 Nov 27.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Objective: The objective of this study was to compare safety and clinical effectiveness of negative-pressure wound therapy (NPWT) with traditional wound therapy for managing noninfected open chests with delayed sternal closure after cardiac surgery.

Methods: From January 2000 to July 2015, 452 of 47,325 patients who underwent full sternotomy left the operating room with a noninfected open chest (0.96%), managed using NPWT in 214-with frequency of use rapidly increasing to near 100%-and traditionally in 238. Predominant indications for open-chest management were uncontrolled coagulopathy or hemodynamic compromise on attempted chest closure. Weighted propensity-score matching was used to assess in-hospital complications and time-related survival.

Results: NPWT and traditionally managed patients had similar high-risk preoperative profiles. Most underwent reoperations (63% of the NPWT group and 57% of the traditional group), and 21% versus 25% were emergency procedures. Reexplorations for bleeding were less common with NPWT versus traditional wound therapy (n = 63 [29%] vs 104 [44%], P = .002). Median duration of open-chest to definitive sternal closure was 3.5 days for NPWT versus 3.1 for traditionally managed patients (P[log rank] = .07). Seven patients (3.3%) were converted from NPWT to traditional therapy because of hemodynamic intolerance and 6 (2.5%) from traditional to NPWT. No NPWT-related cardiovascular injuries occurred. Among matched patients, NPWT was associated with better early survival (61% vs 44% at 6 months; P = .02).

Conclusions: NPWT is safe and effective for managing noninfected open chests after cardiac surgery. By facilitating open-chest management and potentially improving outcomes, it has become our therapy of choice and perhaps has lowered our threshold for leaving the chest open after cardiac surgery.
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http://dx.doi.org/10.1016/j.jtcvs.2018.10.152DOI Listing
May 2019

Contemporary Surgical Management of Hypertrophic Cardiomyopathy in the United States.

Ann Thorac Surg 2019 02 13;107(2):460-466. Epub 2018 Oct 13.

Department of Cardiovascular and Thoracic Surgery, West Virginia University, Morgantown, West Virginia. Electronic address:

Background: The primary surgical therapy for hypertrophic cardiomyopathy with obstruction is septal myectomy (SM). The current outcomes of SM with and without concomitant mitral operations in the United States was examined using The Society of Thoracic Surgeons database.

Methods: From July 2014 through June 2017, 4,274 SM operations were performed. Emergent status, endocarditis, aortic stenosis, and planned aortic valve operations were excluded. In the final cohort of 2,382 patients, 1,581 (66.4%) received SM alone (group 1), and 801 (33.6%) had SM with mitral valve repair or replacement (group 2). Group 2 was subdivided into mitral valve repair (MVr [n = 500]) and mitral valve replacement (MVR [n = 301]). Baseline characteristics were compared and risk-adjusted operative mortality and major morbidity were evaluated between treatment groups.

Results: Baseline comorbidity was lower in group 1 versus group 2 and for MVr versus MVR. Operative mortality and major morbidity was lower for group 1 versus 2 (1.6% versus 2.8%, p = 0.046, and 10.9% versus 20.0%, p < 0.001, respectively). For patients with severe 3-4+ mitral regurgitation, SM alone was effective in reducing mitral regurgitation in 85.5% (355 of 415), and SM with MVr was effective in 88.0% (176 of 200; p = 0.4061). After risk adjustment, odds ratio for composite of mortality and major morbidity for group 2 versus group 1 was 1.8 (95% confidence interval: 1.4 to 2.4, p < 0.0001).

Conclusions: Septal myectomy for hypertrophic cardiomyopathy is safe. Septal myectomy alone may have risk-adjusted outcome advantages over SM with mitral valve repair or replacement. Septal myectomy and SM with MVr provide similar reduction in mitral regurgitation. Further longitudinal analyses are required to define technical efficacy and outcomes in selected pathoanatomic groups.
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http://dx.doi.org/10.1016/j.athoracsur.2018.08.068DOI Listing
February 2019

Late Gadolinium Enhancement in Patients With Hypertrophic Cardiomyopathy and Preserved Systolic Function.

J Am Coll Cardiol 2018 08;72(8):857-870

Hypertrophic Cardiomyopathy Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Background: A high proportion of patients with hypertrophic cardiomyopathy (HCM) have evidence of late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR).

Objectives: This study sought to assess the incremental prognostic utility of LGE in patients with HCM.

Methods: We studied 1,423 consecutive low-/intermediate-risk patients with HCM (age ≥18 years) with preserved left ventricular (LV) ejection fraction (mean age 66 ± 14 years, 60% men) who underwent transthoracic echocardiography (TTE) (including dimensions and LV outflow tract gradients) and CMR (including LGE as a % of LV mass) at our center between January 2008 and December 2015. The primary composite endpoint was sudden cardiac death (SCD) and appropriate implantable cardioverter-defibrillator discharge. The percent 5-year SCD risk score was calculated.

Results: The mean 5-year SCD risk score was 2.3 ± 2.0. Mean maximal LV outflow tract gradient (TTE) was 70 ± 55 mm Hg (median 74 mm Hg [interquartile range (IQR): 10 to 67 mm Hg]); indexed LV mass and LGE (both on CMR) were 91 ± 10 g/m and 8.4 ± 12% (IQR: 0% to 19%); 50% had LGE on CMR. Of these, 458 were nonobstructive and 965 were obstructive (of which 686 were underwent myectomy). At 4.7 ± 2.0 years of follow-up, 60 (4%) met the composite endpoint. On quadratic spline analysis, LGE ≥15% was associated with increased risk of composite events. In the obstructive subgroup, on competing risk regression analysis, ≥15% LGE (subhazard ratio: 3.04 [95% confidence interval: 1.48 to 6.10]) was associated with a higher rate and myectomy (subhazard ratio: 0.44 [95% confidence interval: 0.20 to 0.76]) was associated with a lower rate of composite endpoints (both p < 0.01). Similarly, sequential addition of LGE ≥15% and myectomy to % 5-year SCD risk score improved the log likelihood ratios from -227.85 to -219.14 (chi-square 17) and to -215.14 (chi-square 8; both p < 0.01). Association of %LGE with composite events was similar even in myectomy and nonobstructive subgroups.

Conclusions: In low-/intermediate-risk adult patients with HCM (obstructive, myectomy, and nonobstructive subgroups) with preserved systolic function, %LGE was significantly associated with a higher rate of composite endpoint, providing incremental prognostic utility.
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http://dx.doi.org/10.1016/j.jacc.2018.05.060DOI Listing
August 2018

Continuously Updated Estimation of Heart Transplant Waitlist Mortality.

J Am Coll Cardiol 2018 08;72(6):650-659

Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, Ohio; Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.

Background: Heart transplant allocation in the United States is made on the basis of coarse tiers, defined by mechanical circulatory devices and therapy for advanced heart failure, updated infrequently as a patient's condition deteriorates. Thus, many patients die awaiting heart transplantation. What is needed is a tool that continuously updates risk of mortality as a patient's condition changes to inform clinical decision making.

Objectives: This study sought to develop a decision aid that aggregates adverse events and measures of end-organ function into a continuously updated waitlist mortality estimate.

Methods: From 2008 to 2013, 414 patients were listed for heart transplantation at Cleveland Clinic, Cleveland, Ohio. The endpoint was waitlist death. Pre-listing patient characteristics and events and laboratory results during listing were analyzed. At each event or measurement change, mortality was recomputed from the resulting model.

Results: There were 77 waitlist deaths, with 1- and 4-year survival of 85% and 57%, respectively. When time-varying events and measurements were incorporated into a mortality model, pre-listing patient characteristics became nonsignificant. Neurological events (hazard ratio [HR]: 13.5; 95% confidence interval [CI]: 7.63 to 23.8), new requirement for dialysis (HR: 3.67; 95% CI: 1.88 to 7.14), more respiratory complications (HR: 1.79 per episode; 95% CI: 1.23 to 2.59), and higher serum bilirubin (p < 0.0001) and creatinine (p < 0.0001) yielded continuously updated estimates of patient-specific mortality across the waitlist period.

Conclusions: Mortality risk for patients with advanced heart failure who are listed for transplantation is related to adverse events and end-organ dysfunction that change over time. A continuously updated mortality estimate, combined with clinical evaluation, may inform status changes that could reduce mortality on the heart transplant waiting list.
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http://dx.doi.org/10.1016/j.jacc.2018.05.045DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6298792PMC
August 2018

Prediction of sudden death risk in obstructive hypertrophic cardiomyopathy: Potential for refinement of current criteria.

J Thorac Cardiovasc Surg 2018 08 12;156(2):750-759.e3. Epub 2018 Apr 12.

Hypertrophic Cardiomyopathy Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.

Background: In patients with hypertrophic cardiomyopathy (HCM), the use of an implantable cardioverter defibrillator (ICD) can prevent sudden cardiac death (SCD). In patients with obstructive HCM, we sought to determine the prognostic utility of European Society of Cardiology (ESC) SCD risk score and to evaluate whether additional factors modulate SCD risk.

Methods: We studied 1809 consecutive patients with obstructive HCM (mean age, 50 ± 14 years; 63% males; mean maximal outflow tract gradient, 93 ± 40 mm Hg). Major SCD risk factors were recorded (0, 1, or ≥2) and % 5-year ESC SCD risk score was calculated. The need for surgical myectomy and a composite endpoint (SCD and/or appropriate ICD discharge) were recorded.

Results: The distribution of major SCD risk factors was 0 in 65% of the patients, 1 in 26%, and ≥2 in 8%. The 5-year ESC risk was low (<4%) in 65% of the patients, intermediate (4%-6%) in 18%, and high (>6%) in 17%. Surgery was performed in 1160 patients (64%), and 361 (20%) had AF. At a mean of 8.8 ± 4 years, 169 patients had a composite event (154 SCDs). At 5 years, despite a wide range of expected events (2.5%-9%), the observed events ranged from 4.6% to 5% across 3 SCD risk categories (Hosmer-Lemeshow P = .32). On multivariable competing-risk analysis, myectomy (subdistribution hazard ratio [sHR], 0.69; 95% confidence interval [CI], 0.47-0.83) was associated with lower risk of longer-term composite events (P < .01), whereas ESC SCD risk score was not (sHR, 1.31; 95% CI, 0.75-2.25; P = .36).

Conclusions: In patients with obstructive HCM, despite a wide range of expected 5-year primary event rate, the observed primary events were similar across the 3 ESC SCD risk categories, with myectomy mitigating SCD risk. In patients with obstructive HCM, SCD risk may need to be refined for patients following myectomy.
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http://dx.doi.org/10.1016/j.jtcvs.2018.03.150DOI Listing
August 2018

Hypertrophic cardiomyopathy: A complex disease.

Cleve Clin J Med 2018 May;85(5):399-411

Robert and Suzanne Tomsich Department of Cardiovascular Medicine, Heart and Vascular Institute, and Department of Diagnostic Radiology, Cleveland Clinic, Cleveland, OH, USA.

Hypertrophic cardiomyopathy (HCM) is a complex cardiovascular disease with wide phenotypic variations. Despite significant advances in imaging and genetic testing, more information is needed about the roles and implications of these resources in clinical practice. Patients with suspected or established HCM should be evaluated at an expert referral center to allow for the best multidisciplinary care. Research is needed to better predict the risk of sudden cardiac death in those judged to be at low risk by current risk-stratification methods.
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http://dx.doi.org/10.3949/ccjm.85a.17076DOI Listing
May 2018

Genetic Control of Left Atrial Gene Expression Yields Insights into the Genetic Susceptibility for Atrial Fibrillation.

Circ Genom Precis Med 2018 03;11(3):e002107

From the Departments of Cellular and Molecular Medicine (J.H., G.T., J.D.S.), Quantitative Health Sciences (J.B.), Molecular Cardiology (S.G.-P., L.C., B.L., C.S.M., D.R.V.W., M.K.C.), Cardiovascular Medicine (C.S.M., D.R.V.W., M.K.C., J.D.S.), and Cardiothoracic Surgery (G.B.P., E.E.R., A.M.G., K.R.M., N.G.S.), Cleveland Clinic, Cleveland, OH.

Background: Genome-wide association studies have identified 23 loci for atrial fibrillation (AF), but the mechanisms responsible for these associations, as well as the causal genes and genetic variants, remain undefined.

Methods: To identify the effect of common genetic variants on gene expression that might explain the mechanisms linking genome-wide association loci with AF risk, we performed RNA sequencing of left atrial appendages from a biracial cohort of 265 subjects.

Results: Combining gene expression data with genome-wide single nucleotide polymorphism data, we found that approximately two-thirds of the expressed genes were regulated in by common genetic variants at a false discovery rate of <0.05, defined as cis-expression quantitative trait loci. Twelve of 23 reported AF genome-wide association loci displayed genome-wide significant -expression quantitative trait loci, at (chromosome 1q24), (1q24), (2p14), (2q31), (5q22), (5q31), (7q31), (8p22), (10q22), (11q24), (12q24), and (14q23), suggesting that altered expression of these genes plays a role in AF susceptibility. Allelic expression imbalance was used as an independent method to characterize the cis-control of gene expression. One thousand two hundred forty-eight of 5153 queried genes had -single nucleotide polymorphisms that significantly regulated allelic expression at a false discovery rate of <0.05.

Conclusions: We provide a genome-wide catalog of the genetic control of gene expression in human left atrial appendage. These data can be used to confirm the relevance of genome-wide association loci and to direct future functional studies to identify the genes and genetic variants responsible for complex diseases such as AF.
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http://dx.doi.org/10.1161/CIRCGEN.118.002107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5858469PMC
March 2018

Incremental Prognostic Utility of Left Ventricular Global Longitudinal Strain in Hypertrophic Obstructive Cardiomyopathy Patients and Preserved Left Ventricular Ejection Fraction.

J Am Heart Assoc 2017 Oct 20;6(10). Epub 2017 Oct 20.

Hypertrophic Cardiomyopathy Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH

Background: In obstructive hypertrophic cardiomyopathy patients with preserved left ventricular (LV) ejection fraction, we sought to determine whether LV global longitudinal strain (LV-GLS) provided incremental prognostic utility.

Methods And Results: We studied 1019 patients with documented hypertrophic cardiomyopathy (mean age, 50±12 years; 63% men) evaluated at our center between 2001 and 2011. We excluded age <18 years, maximal LV outflow tract gradient <30 mm Hg, bundle branch block or atrial fibrillation, past pacemaker/cardiac surgery, including myectomy/alcohol ablation, and obstructive coronary artery disease. Average resting LV-GLS was measured offline on 2-, 3-, 4-chamber views using Velocity Vector Imaging (Siemens, Malvern, PA). Outcome was a composite of cardiac death and appropriate internal defibrillator (implantable cardioverter defibrillator) discharge. Maximal LV thickness, LV ejection fraction, indexed left atrial dimension, rest and maximal LV outflow tract gradient, and LV-GLS were 2.0±0.2 cm, 62±4%, 2.2±4 cm/m, 52±42 mm Hg, 103±36 mm Hg, and -13.6±4%. During 9.4±3 years of follow-up, 668 (66%), 166 (16%), and 122 (20%), respectively, had myectomy, atrial fibrillation, and implantable cardioverter defibrillator implantation, whereas 69 (7%) had composite events (62 cardiac deaths). Multivariable competing risk regression analysis revealed that higher age (subhazard ratio, 1.04 [1.02-1.07]), AF during follow-up (subhazard ratio, 1.39 [1.11-1.69]), and worsening LV-GLS (subhazard ratio, 1.11 [1.05-1.22]) were associated with worse outcomes, whereas myectomy (subhazard ratio, 0.44 [0.25-0.72]) was associated with improved outcomes (all <0.01). Sixty-one percent of events occurred in patients with LV-GLS worse than median (-13.7%).

Conclusions: In obstructive hypertrophic cardiomyopathy patients with preserved LV ejection fraction, abnormal LV-GLS was independently associated with higher events, whereas myectomy was associated with improved outcomes.
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http://dx.doi.org/10.1161/JAHA.117.006514DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5721859PMC
October 2017

Successful treatment of aortic root dissection complicated with extensive myocardial infarction using the total artificial heart.

J Surg Case Rep 2017 Aug 30;2017(8):rjx123. Epub 2017 Aug 30.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.

Acute Type A aortic dissection is a surgical emergency. Urgent repair is indicated to avoid complications such as acute aortic insufficiency, coronary ischemia and aortic rupture with cardiac tamponade. This report details the management of a patient with acute Type A aortic dissection complicated by an extensive anterolateral myocardial infarction and cardiogenic shock who was successfully bridged to transplantation with a total artificial heart.
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http://dx.doi.org/10.1093/jscr/rjx123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5577501PMC
August 2017

Pulmonary thromboendarterectomy in the setting of a mediastinal venous malformation with a congenitally absent left subclavian vein.

Pulm Circ 2017 Mar 1;7(1):256-260. Epub 2017 Feb 1.

Vascular Malformation Center, Swedish Medical Center, Englewood, CO, USA.

Venous malformations have static venous lakes that predispose to spontaneous venous thrombosis within the malformation due to its low-flow static state. Thrombi of varying sizes can then embolize continually into the pulmonary arterial circulation, and occlude and narrow elastic pulmonary arteries causing chronic thromboembolic pulmonary hypertension (CTEPH). Pulmonary thromboendarterectomy (PTE) is potentially curative in CTEPH, but has not been previously reported in the setting of mediastinal and chest wall venous malformations. We report the case of a 21-year-old female with such a large malformation treated successfully with PTE. The patient underwent complete endovascular reconstruction of her subclavian vein system from the axillary vein to the innominate vein stump with covered stent grafts to exclude the malformations from causing recurrent pulmonary emboli. This was followed by embolization of the malformation to allow for the surgical approach. The series of events in this case serves as a novel approach in managing such rare patients.
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http://dx.doi.org/10.1086/689751DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5448542PMC
March 2017

Optimal Timing of Heart Transplant After HeartMate II Left Ventricular Assist Device Implantation.

Ann Thorac Surg 2017 Nov 24;104(5):1569-1576. Epub 2017 Jun 24.

Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio; Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, Ohio.

Background: Optimal timing of heart transplantation in patients supported with second-generation left ventricular assist devices (LVADs) is unknown. Despite this, patients with LVADs continue to receive priority on the heart transplant waiting list. Our objective was to determine the optimal timing of transplantation for patients bridged with continuous-flow LVADs.

Methods: A total of 301 HeartMate II LVADs (Thoratec Corp, Pleasanton, CA) were implanted in 285 patients from October 2004 to June 2013, and 86 patients underwent transplantation through the end of follow-up. Optimal transplantation timing was the product of surviving on LVAD support and surviving transplant.

Results: Three-year survival after both HeartMate II implantation and heart transplantation was unchanged when transplantation occurred within 9 months of implantation. Survival decreased as the duration of support exceeded this. Preoperative risk factors for death on HeartMate II support were prior valve operation, prior coronary artery bypass grafting, low albumin, low glomerular filtration rate, higher mean arterial pressure, hypertension, and earlier date of implant. Survival for patients without these risk factors was lowest when transplant was performed within 3 months but was relatively constant with increased duration of support. Longer duration of support was associated with poorer survival for patients with many of these risk factors. Device reimplantation, intracranial hemorrhage, and postimplant dialysis during HeartMate II support were associated with decreased survival.

Conclusions: Survival of patients supported by the HeartMate II is affected by preoperative comorbidities and postoperative complications. Transplantation before complications is imperative in optimizing survival.
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http://dx.doi.org/10.1016/j.athoracsur.2017.03.066DOI Listing
November 2017

Long-Term Outcomes of Patients With Mediastinal Radiation-Associated Severe Aortic Stenosis and Subsequent Surgical Aortic Valve Replacement: A Matched Cohort Study.

J Am Heart Assoc 2017 May 5;6(5). Epub 2017 May 5.

Centers for Radiation Heart Disease and Heart Valve Disease, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH

Background: Cardiac disease after mediastinal radiotherapy for thoracic malignancy (chest radiotherapy [XRT]) often manifests as progressive aortic stenosis. In patients with XRT-induced severe aortic stenosis undergoing surgical aortic valve replacement (SAVR), we sought to: (1) study long-term survival and compare these patients with a matched cohort undergoing SAVR during the same time frame; and (2) identify potential predictors of long-term mortality.

Methods And Results: We studied patients with symptomatic severe aortic stenosis undergoing SAVR at our institution, of which there were 172 mediastinal XRT patients (63±13 years, 62% women) matched in a 1:1 fashion (based on age, sex, time of surgery, and aortic valve area) with 172 non-XRT patients (comparison group). Baseline clinical and postoperative data were obtained. Society of Thoracic Surgeons score was calculated and mortality was recorded. In the XRT group, the median Society of Thoracic Surgeons score was 4% (interquartile range 2-13), while mean left ventricular ejection fraction, left ventricular stroke volume index, and mean aortic valve gradient were 54±11%, 38±14 mL/m, and 39±11 mm Hg, respectively. In the entire cohort, 27% and 34% of patients underwent concomitant coronary artery bypass grafting and aortic surgery at the time of SAVR, respectively. Thirty-day/in-hospital deaths occurred in 4 (2%) patients in the XRT group and 0 patients in the comparison group. At 6±3 years of follow-up, on matched group analysis, there were 95 (28%) deaths (83 [48%] in the XRT group versus 12 [7%] in the comparison group (log-rank 89, <0.001). On multivariable Cox survival analysis, in the whole cohort, higher Society of Thoracic Surgeons score (hazard ratio, 1.14; 95% CI, 1.03-1.26) and mediastinal XRT (hazard ratio, 8.12; 95% CI, 4.26-15.64) were associated with increased longer-term mortality (both <0.01).

Conclusions: In patients with severe aortic stenosis undergoing SAVR, patients with prior mediastinal XRT have significantly worse longer-term survival versus a matched cohort.
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http://dx.doi.org/10.1161/JAHA.116.005396DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5524090PMC
May 2017

Comparison of Ventricular Septal Measurements in Hypertrophic Cardiomyopathy Patients Who Underwent Surgical Myectomy Using Multimodality Imaging and Implications for Diagnosis and Management.

Am J Cardiol 2017 05 1;119(10):1656-1662. Epub 2017 Mar 1.

Hypertrophic Cardiomyopathy Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address:

Accurate and reproducible quantification of ventricular septal (VS) thickness in hypertrophic cardiomyopathy (HC) is essential for diagnosis, surgical planning, and risk stratification. We sought to compare VS thickness measurements using transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and cardiac magnetic resonance (CMR) in patients with HC. Prospectively reported measurements of VS thickness were compared using analysis of variance and Bland-Altman plots in 90 consecutive patients with HC who underwent a TTE, TEE, and CMR within 3 months. A subset was re-measured on 2 separate occasions by 2 readers to assess inter- and intraobserver variability. There was modest correlation between modalities, with CMR and TTE measurements of VS thickness showing the greatest correlation (CMR vs TTE, r = 0.70; CMR vs TEE, r = 0.60; TTE vs TEE, r = 0.56). Smaller measurements were seen using CMR versus either echocardiographic technique (13% smaller vs TEE, 8% smaller vs TTE, p <0.001 for both). The variability of measurement between modalities was not correlated with the degree of VS thickness. There was significantly lower intraobserver variability with CMR versus echocardiography (p = 0.01 for both), but no difference in interobserver variability. CMR delineated a different area of maximal VS thickness other than the basal anteroseptum more frequently than echocardiography (44% of cases vs 24% for TTE and 11% for TEE). In conclusion, CMR assessment of VS thickness differs significantly from echocardiography in patients with HC, with a systemic bias toward lower measurements seen with CMR.
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http://dx.doi.org/10.1016/j.amjcard.2017.02.009DOI Listing
May 2017

Outcomes in hypertrophic cardiomyopathy patients with and without atrial fibrillation: a survival meta-analysis.

Cardiovasc Diagn Ther 2017 Feb;7(1):36-44

Hypertrophic Cardiomyopathy Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH, USA.

Background: Atrial fibrillation (AF) is a frequent occurrence in patients with hypertrophic cardiomyopathy (HCM). It is associated with worsening symptoms, cardiovascular events, and mortality. We conducted a meta-analysis of studies reporting on mortality in patient with HCM and AF.

Methods: We searched PubMed, Medline, Embase, Ovid and Cochrane for studies which reported cardiovascular events and mortality in patients with HCM and AF. Outcome was a composite of cardiac mortality and/or all-cause mortality. Mantel Haenszel odds ratio (OR) or hazard ratio (HR) were calculated using random-effects meta-analysis for the prespecified outcome. Heterogeneity was assessed using I statistics.

Results: Six studies met the inclusion criteria. There were 6,858 patients; 1,314 (19%) had history of AF. During a mean follow up that ranged between 4 and 8 years, 405 (30.8%) patients with AF died as compared to 1,011 (18.2%) patients without AF (OR =2.49, 95% CI: 1.85-3.35, P<0.00001, I=57%). Results persisted with inclusion of studies only reporting specifically on cardiac mortality (OR =2.80, 95% CI: 1.79-4.39, P<0.00001, I=56%). Also, the mortality difference persisted after exclusion of deaths secondary to stroke in both groups (2 studies, 1,398 patients, OR =2.57, 95% CI: 1.57-4.20, P=0.0002, I=31%). In three studies (5,857 patients); the presence of AF was associated with a pooled HR of 1.66 (95% CI: 1.29-2.13, P<0.0001, I=41%).

Conclusion: Patients with HCM who develop AF have higher risk of mortality and cardiac deaths as compared to HCM patients without AF.
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http://dx.doi.org/10.21037/cdt.2016.11.23DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5253453PMC
February 2017

Abnormalities of Mitral Subvalvular Apparatus in Hypertrophic Cardiomyopathy: Role of Intraoperative 3D Transesophageal Echocardiography.

Anesth Analg 2016 11;123(5):1094-1097

From the *Department of Cardiothoracic Anesthesiology; and †Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.

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http://dx.doi.org/10.1213/ANE.0000000000001553DOI Listing
November 2016

Saving 2 lives with 1 operation!

J Thorac Cardiovasc Surg 2016 Apr 12;151(4):1161-2. Epub 2016 Jan 12.

Department of Thoracic/Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address:

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http://dx.doi.org/10.1016/j.jtcvs.2016.01.015DOI Listing
April 2016
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