Hemal Gada

Rutgers New Jersey Medical School, Newark, New Jersey, United States

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Publications (25)221.67 Total impact

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    ABSTRACT: In the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. We evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales. Despite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894. © 2015 American Heart Association, Inc.
    Circulation Cardiovascular Quality and Outcomes 06/2015; 8(4). DOI:10.1161/CIRCOUTCOMES.114.001335 · 5.66 Impact Factor

  • Journal of the American College of Cardiology 03/2015; 65(10):A1736. DOI:10.1016/S0735-1097(15)61736-3 · 16.50 Impact Factor

  • Journal of the American College of Cardiology 03/2015; 65(10):A1767. DOI:10.1016/S0735-1097(15)61767-3 · 16.50 Impact Factor
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    ABSTRACT: Outcomes of percutaneous coronary intervention (PCI) versus medical therapy (MT) in the management of stable ischemic heart disease (SIHD) remain controversial, with some but not all studies showing improved results in patients with ischemia. We sought to elucidate whether PCI improves mortality compared to MT in patients with objective evidence of ischemia (assessed using noninvasive imaging or its invasive equivalent). We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing PCI to MT in patients with SIHD. To maintain a high degree of specificity for ischemia, studies were only included if ischemia was defined on the basis of noninvasive stress imaging or abnormal fractional flow reserve. The primary outcome was all-cause mortality. We identified 3 RCTs (Effects of Percutaneous Coronary Interventions in Silent Ischemia After Myocardial Infarction II, Fractional Flow Reserve versus Angiography for Multivessel Evaluation 2, and a substudy of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation trial) enrolling a total of 1,557 patients followed for an average of 3.0 years. When compared with MT in this population of patients with objective ischemia, PCI was associated with lower mortality (hazard ratio 0.52, 95% confidence interval 0.30 to 0.92, p = 0.02). There was no evidence of study heterogeneity or bias among included trials. In this meta-analysis of published RCTs, PCI was shown to have a mortality benefit over MT in patients with SIHD and objective assessment of ischemia using noninvasive imaging or its invasive equivalent. In conclusion, this study provides insight into the management of a higher-risk SIHD population that is the focus of the ongoing International Study of Comparative Health Effectiveness with Medical and Invasive Approaches trial. Copyright © 2015 Elsevier Inc. All rights reserved.
    The American Journal of Cardiology 02/2015; 115(9). DOI:10.1016/j.amjcard.2015.01.556 · 3.28 Impact Factor
  • Hemal Gada · Jeffrey W Moses ·
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    ABSTRACT: The 2009 Appropriate Use Criteria (AUC) for coronary revascularization were designed to optimize care given deficient practice guidelines. However, due to the constituency of its technical panel and limitations in methodology, the noble intent of the AUC has shifted to use as a punitive tool to eradicate perceived overuse of percutaneous coronary intervention (PCI). In analyzing the current literature, there does not appear to be significant PCI overuse. Moreover, several studies have identified PCI underuse and its resultant hazards. In the 2012 focused update, there has been no substantive change to its flawed conception and application. We describe problems related to the development of the AUC and its use in clinical practice, suggesting several modifications to guide relevant future iterations.
    02/2015; 7(1):27-33. DOI:10.2217/ica.14.63
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    ABSTRACT: Background: In patients with severe aortic stenosis, transcatheter aortic valve replacement (TAVR) improves survival when compared with nonsurgical therapy but with higher in-hospital and lifetime costs. Complications associated with TAVR may decrease with greater experience and improved devices, thereby reducing the overall cost of the procedure. Therefore, we sought to estimate the effect of periprocedural complications on in-hospital costs and length of stay of TAVR. Methods and results: Using detailed cost data from 406 TAVR patients enrolled in the Placement of Aortic Transcatheter Valve (PARTNER) I trial, we developed multivariable models to estimate the incremental cost and length of stay associated with specific periprocedural complications. Attributable costs and length of stay for each complication were calculated by multiplying the independent cost of each event by its frequency in the treatment group. Mean cost for the initial hospitalization was $79 619±40 570 ($50 891 excluding the valve); 49% of patients had ≥1 complication. Seven complications were independently associated with increased hospital costs, with major bleeding, arrhythmia, and death accounting for the largest attributable cost per patient. Renal failure and the need for repeat TAVR, although less frequent, were also associated with substantial incremental and attributable costs. Overall, complications accounted for $12 475 per patient in initial hospital costs and 2.4 days of hospitalization. Conclusions: In the PARTNER trial, periprocedural complications were frequent, costly, and accounted for ≈25% of non-implant-related hospital costs. Avoidance of complications should improve the cost-effectiveness of TAVR for inoperable and high-risk patients, but reductions in the cost of uncomplicated TAVR will also be necessary for optimal efficiency. Clinical trial registration url: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.
    Circulation Cardiovascular Interventions 10/2014; 63(12). DOI:10.1161/CIRCINTERVENTIONS.114.001395 · 6.22 Impact Factor

  • Journal of the American College of Cardiology 09/2014; 64(11):B194-B195. DOI:10.1016/j.jacc.2014.07.739 · 16.50 Impact Factor

  • Journal of the American College of Cardiology 09/2014; 64(11):B74-B75. DOI:10.1016/j.jacc.2014.07.297 · 16.50 Impact Factor
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    ABSTRACT: OBJECTIVES This study sought to determine the impact of quantity and location of aortic valve calcification (AVC) on paravalvular regurgitation (PVR) and rates of post-dilation (PD) immediately after transcatheter aortic valve replacement (TAVR). BACKGROUND The impact of AVC in different locations within the aortic valve complex is incompletely understood. METHODS This study analyzed 150 patients with severe, symptomatic aortic stenosis who underwent TAVR. Total AVC volume scores were calculated from contrast-enhanced multidetector row computed tomography imaging. AVC was divided by leaflet sector and region (Leaflet, Annulus, left ventricular outflow tract [LVOT]), and a combination of LVOT and Annulus (AnnulusLVOT). Asymmetry was assessed. Receiver-operating characteristic analysis was performed with greater than or equal to mild PVR and PD as classification variables. Logistic regression was performed. RESULTS Quantity of and asymmetry of AVC for all regions of the aortic valve complex predicted greater than or equal to mild PVR by receiver-operating characteristic analysis (area under the curve = 0.635 to 0.689), except Leaflet asymmetry. Receiver-operating characteristic analysis for PD was significant for quantity and asymmetry of AVC in all regions, with higher area under the curve values than for PVR (area under the curve = 0.648 to 0.741). On multivariable analysis, Leaflet and AnnulusLVOT calcification were independent predictors of both PVR and PD regardless of multidetector row computed tomography area cover index. CONCLUSIONS Quantity and asymmetry of AVC in all regions of the aortic valve complex predict greater than or equal to mild PVR and performance of PD, with the exception of Leaflet asymmetry. Quantity of AnnulusLVOT and Leaflet calcification independently predict PVR and PD when taking into account multidetector row computed tomography area cover index. (C) 2014 by the American College of Cardiology Foundation.
    JACC Cardiovascular Interventions 08/2014; 7(8):885-94. DOI:10.1016/j.jcin.2014.03.007 · 7.35 Impact Factor
  • Martin B. Leon · Hemal Gada · Gregory P. Fontana ·
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    ABSTRACT: Background Transcatheter aortic valve replacement (TAVR) is a novel less-invasive therapy for high-risk patients with severe aortic stenosis (AS). Despite the impressive clinical growth of TAVR, there are many challenges as well as future opportunities. Results The heart valve team serves as the central vehicle for determining appropriate case selection. Considerations which impact clinical therapy decisions include frailty assessments and defining clinical “futility”. There are many controversial procedural issues; choice of vascular access site, valve sizing, adjunctive imaging, and post-dilatation strategies. Complications associated with TAVR (strokes, vascular and bleeding events, para-valvular regurgitation, and conduction abnormalities) must be improved and will require procedural and/or technology enhancements. TAVR site training mandates a rigorous commitment to established society and sponsor guidelines. In the future, TAVR clinical indications should extend to bioprosthetic valve failure, intermediate risk patients, and other clinical scenarios, based upon well conducted clinical trials. New TAVR systems have been developed which should further optimize clinical outcomes, by reducing device profile, providing retrievable features, and preventing para-valvular regurgitation. Other accessory devices, such as cerebral protection to prevent strokes, are also being developed and evaluated in clinical studies. Summary TAVR is a worthwhile addition to the armamentarium of therapies for patients with AS. Current limitations are important to recognize and future opportunities to improve clinical outcomes are being explored.
    Progress in Cardiovascular Diseases 05/2014; 56(6). DOI:10.1016/j.pcad.2014.03.004 · 2.42 Impact Factor
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    Journal of the American College of Cardiology 04/2014; 63(12):A1036. DOI:10.1016/S0735-1097(14)61036-6 · 16.50 Impact Factor
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    Journal of the American College of Cardiology 04/2014; 63(12):A1024. DOI:10.1016/S0735-1097(14)61024-X · 16.50 Impact Factor
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    ABSTRACT: Great strides have been made in improving outcomes for patients with ST-elevation myocardial infarction (STEMI), predominately through initiatives focusing upon improving clinical processes "upstream" of percutaneous coronary intervention (PCI). The actual step-by-step mechanics of diagnostic angiography during STEMI and other aspects of the PCI procedure itself have received relatively little attention. We hypothesized that there would be significant variation in how primary PCI for STEMI is performed in the United States. In order to better understand current US practice, an electronic survey consisting of seven focused questions was forwarded to 2,910 US interventional cardiologists who were members of the Society for Cardiovascular Angiography and Interventions (SCAI). Three hundred sixty-two responses were received (12.4%). Among respondents, the femoral artery was the preferred access site in 83% (vs. 17% radial). The use of a diagnostic catheter to visualize the non-culprit artery prior to using a guiding catheter for the culprit artery was the preferred approach for 58% of respondents, and an additional 23% preferred complete angiography with diagnostic catheters prior to guide insertion. However, a significant minority (19%) preferred starting directly with a guide catheter for the culprit artery and performing PCI prior to contralateral non-culprit artery visualization. Only 9% reported performing routine left ventriculography prior to PCI, with the majority (66%) choosing to perform ventriculography during/after PCI, and 25% reporting rare or no use of left ventriculography. Fewer than half of respondents (49%) reported routine aspiration thrombectomy use, despite a Class IIa ACC/AHA guidelines recommendation. There is significant variability in the self-reported mechanics of primary PCI by US interventional cardiologists. Some of this variability (e.g., sequence of catheters, and performance of left ventriculography prior to reperfusion) is not addressed by current guidelines/consensus documents, and may have clinical implications, reflecting the balance between the desire for timely reperfusion versus a more complete assessment of patient risk. © 2013 Wiley Periodicals, Inc.
    Catheterization and Cardiovascular Interventions 04/2014; 83(5). DOI:10.1002/ccd.25276 · 2.11 Impact Factor
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    ABSTRACT: Transcatheter aortic valve implantation (TAVI) has emerged as an alternative treatment to aortic valve replacement (AVR) for selected patients with severe aortic stenosis. The present systematic review was conducted to analyze the cost-effectiveness of this novel technique within reimbursed healthcare systems. Two reviewers used 7 electronic databases from January 2000 to November 2012 to identify relevant cost-effectiveness studies of TAVI versus AVR or medical therapy. The primary endpoints were the incremental cost-effectiveness ratio (ICER) and the probability of cost-effectiveness. The eligible studies for the present systematic review included those in which the cost-effectiveness data were measured or projected for TAVI and either medical therapy or AVR. All forms of TAVI were included, and all retrieved publications were limited to the English language. Eight studies were included for quantitative assessment. The ICER for TAVI compared with medical therapy for surgically inoperable patients ranged from US$26,302 to US$61,889 per quality-adjusted life year gained. The probability of TAVI being cost-effective compared with medical therapy ranged from 0.03 to 1.00. The ICER values for TAVI compared with AVR for high-risk surgical candidates ranged from US$32,000 to US$975,697 per quality-adjusted life year gained. The probability of TAVI being cost-effective in this cohort ranged from 0.116 to 0.709. Depending on the ICER threshold selected, TAVI is potentially justified on both medical and economic grounds compared with medical therapy for patients deemed to be surgically inoperable. However, in the high-risk surgical patient cohort, the evidence is currently insufficient to economically justify the use of TAVI in preference to AVR.
    The Journal of thoracic and cardiovascular surgery 11/2013; 148(2). DOI:10.1016/j.jtcvs.2013.10.023 · 4.17 Impact Factor
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    ABSTRACT: We sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease. The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up. SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES vs PES. Endpoints included ischemia-driven target vessel failure (TVF: death, myocardial infarction, (MI) or ischemia-driven target vessel revascularization [TVR]), the prespecified primary endpoint), target lesion failure (TLF; cardiac death, target-vessel MI or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE; cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis. Five-year follow-up was available in 91.9% of patients. Treatment with EES vs. PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p=0.05), TLF (12.7% vs. 19.0%, p=0.008), and MACE (13.2% vs. 20.7%, p=0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p=0.02), with non-significantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time. At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.
    JACC. Cardiovascular Interventions 11/2013; 6(12). DOI:10.1016/j.jcin.2013.07.009 · 7.35 Impact Factor
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    Journal of the American College of Cardiology 10/2013; 62(18). DOI:10.1016/j.jacc.2013.08.1599 · 16.50 Impact Factor
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    Circulation 04/2013; 127(14):1536-7. DOI:10.1161/CIRCULATIONAHA.112.111468 · 14.43 Impact Factor
  • Hemal Gada · Patrick L Whitlow · Thomas H Marwick ·
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    ABSTRACT: Background In the setting of chronic stable angina, successful percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) has been shown to produce significant symptom improvement with some evidence for survival benefit. However, the economic basis for this procedure has not been established compared with optimal medical treatment (OMT) of chronic stable angina. Objective The aim of this study was to determine the cost-effectiveness of CTO-PCI in chronic stable angina using a Markov model. Design The transition probabilities, utilities and costs related to CTO-PCI and OMT used to inform the model were derived from literature and our experience. Implications with respect to cost and quality of life were calculated. Sensitivity analyses were based on factors noted to influence model outcome. Results In the reference case, mean age 60 years, rate of successful CTO-PCI 67.9%, and mean transition probabilities, utilities and costs as defined by literature and clinical experience, the strategy of CTO-PCI incurred higher costs relative to OMT (US$31 512 vs US$27 805), but also accumulated greater quality-adjusted life-years (QALYs) (2.38 vs 1.99), yielding a cost-effectiveness ratio of US$9505 per QALY. Sensitivity analyses showed the utility of OMT and utilities postsuccessful and postunsuccessful CTO-PCI to be the most influential drivers of outcome. Procedural success held limited influence over model outcome at particular utility threshold values. Conclusions On the basis of the supporting evidence, this decision-analytic model suggests that CTO-PCI is cost-effective in a patient population with severe symptoms. Quality-of-life metrics should be employed in future appropriateness criteria developed for CTO-PCI.
    Heart (British Cardiac Society) 10/2012; 98(24). DOI:10.1136/heartjnl-2012-302581 · 5.60 Impact Factor
  • Hemal Gada · Milind Y Desai · Thomas H Marwick ·
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    ABSTRACT: Background: The risks of repeat thoracotomy can be reduced if thoracic multidetector computed tomographic angiography (CTA) is used to guide preventive surgical strategies (PSS: peripheral cardiopulmonary bypass, circulatory arrest, and non-median sternotomy). We sought to define the cost-effectiveness of CTA using a Markov model. Methods and results: We studied outcomes and costs of CTA and non-CTA strategies in a modeled cohort of 10 000 patients undergoing redo coronary artery bypass grafting. Rates of PSS implementation were anticipated to follow identification of risk by CTA. Transitions, costs, and utilities were informed by our experience and the literature. Sensitivity analyses included testing a range of costs of CTA and PSS on model outcome. In the reference case, cost and quality-adjusted life years accrued with the use of CTA ($74 869, 4.63 quality-adjusted life-years) were slightly higher than nonuse ($73 471, 4.59 quality-adjusted life-years), yielding an incremental cost-effectiveness ratio of $34 950/quality-adjusted life-years. Cost of PSS (equipment and operating time) was the most significant determinant of incremental cost-effectiveness ratio. In the reference case (cost of CTA ≈$300), identification and avoidance of potential procedural difficulties with CTA rendered it cost-effective if the cost of PSS was <$12 000. Across a range of CTA costs, incremental cost-effectiveness ratio was not materially influenced by outcomes across a broad range of imputed values. Conclusions: The cost of CTA appears justified in the setting of isolated reoperative coronary artery bypass grafting, because it aids in appropriate selection of PSS. The cost-effectiveness of this imaging seems more influenced by the costs of subsequent PSS than by the cost of CTA.
    Circulation Cardiovascular Quality and Outcomes 08/2012; 5(5):705-10. DOI:10.1161/CIRCOUTCOMES.112.966465 · 5.66 Impact Factor
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    Hemal Gada · Shikhar Agarwal · Thomas H Marwick ·
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    ABSTRACT: The incremental cost-effectiveness of transapical transcatheter aortic valve implantation (TAVI) is ill-defined in high-risk patients where aortic valve replacement (AVR) is an option, and has not been ascertained outside a randomized controlled trial. We developed a Markov model to examine the progression of patients between health states, defined as peri- and post-procedural, post-complication, and death. The mean and variance of risks, transition probabilities, utilities and cost of transapical TAVI, high-risk AVR, and medical management were derived from analysis of relevant registries. Outcome and cost were derived from 10,000 simulations. Sensitivity analyses further evaluated the impact of mortality, stroke, and other commonly observed outcomes. In the reference case, both transapical TAVI and high-risk AVR and TAVI were cost-effective when compared to medical management ($44,384/QALY and $42,637/QALY, respectively). Transapical TAVI failed to meet accepted criteria for incremental cost-effectiveness relative to AVR, which was the dominant strategy. In sensitivity analyses, the mortality rates related to the two strategies, the utilities post-AVR and post-transapical TAVI, and the cost of transapical TAVI, were the main drivers of model outcome. Transapical TAVI did not satisfy current metrics of incremental cost-effectiveness relative to high-risk AVR in the reference case. However, it may provide net health benefits at acceptable cost in selected high-risk patients among whom AVR is the standard intervention.
    07/2012; 1(2):145-55. DOI:10.3978/j.issn.2225-319X.2012.06.12

Publication Stats

100 Citations
221.67 Total Impact Points


  • 2015
    • Rutgers New Jersey Medical School
      • Department of Medicine
      Newark, New Jersey, United States
  • 2013-2014
    • New York Presbyterian Hospital
      • Department of Cardiology
      New York, New York, United States
    • Columbia University
      New York, New York, United States
    • Macquarie University
      Sydney, New South Wales, Australia
  • 2012
    • Cleveland Clinic
      Cleveland, Ohio, United States