PICO Search Assignment Worksheet Name: C. Shamrock, PA-S
N.M. is a 52 y/o M with PMH of well controlled DM and HTN who was diagnosed with aortic stenosis requiring a surgical intervention. His doctor recommended an open-heart surgery, but he is reluctant to agree to it and is asking if a transcatheter aortic valve replacement is a good option for him.
Search Question:
Is Surgical Aortic Valve replacement (SAVR) superior to Transcatheter approach (TAVR) for intermediate risk patients in terms of mortality, rates of endocarditis, and stroke?
Question Type: What kind of question is this?
☐Prevalence ☐Screening ☐Diagnosis
☒Prognosis ☒Treatment ☐Harms
This is a treatment/outcome clinical question, therefore the ranking of level of evidence will be
Syst. Review > RCT > Cohort > Case Control > Case series
I am going to attempt to find at least one systematic review since they offer a suggestion/answer derived from vast amount of data. However, I would also like to focus on RCTs because they offer more precision. Cohort study would be acceptable as well since I am monitoring a set of outcomes. Retrospective Analysis is also appropriate since I am looking at long term outcomes.
PICO search terms:
| P | I | C | O |
| Aortic Stenosis patients with intermediate risk for perioperative Cardiac complications | TAVR | SAVR | Endocarditis |
| Open Heart Surgery | Mortality | ||
| Length of Stay | |||
| Postoperative Ventricular Blocks | |||
| Postoperative Pacemaker implantation | |||
| Stroke | |||
| Paravalvular Aortic Regurgitation | |||
| Atrial Fibrillation |
Results found:
Pub Med :
- Search words: endocarditis, aortic valve, TAVR, SAVR, low risk, aortic stenosis, aortic valve, surgery, transcatheter aortic valve, transcatheter aortic valve implantation, Aortic Valve Replacement/Transcather Aortic Valve Implantation, Quality and Outcomes, Valvular Heart Disease, Treatment, Catheter-Based Coronary and Valvular Interventions
- Filter “published between 2016 and now”
- 1931 results
TRIP:
- Search words: endocarditis, aortic valve, TAVR, SAVR, low risk, aortic stenosis, aortic valve, surgery, transcatheter aortic valve, transcatheter aortic valve implantation, Aortic Valve Replacement/Transcather Aortic Valve Implantation, Quality and Outcomes, Valvular Heart Disease, Treatment, Catheter-Based Coronary and Valvular Interventions
- 14 results
JAMA:
- Search words: endocarditis, aortic valve, TAVR, SAVR, low risk, aortic stenosis, aortic valve, surgery, transcatheter aortic valve, transcatheter aortic valve implantation, Aortic Valve Replacement/Transcather Aortic Valve Implantation, Quality and Outcomes, Valvular Heart Disease, Treatment, Catheter-Based Coronary and Valvular Interventions
- 18 results
Science Direct:
- Search words: endocarditis, aortic valve, TAVR, SAVR, low risk, aortic stenosis, aortic valve, surgery, transcatheter aortic valve, transcatheter aortic valve implantation, Aortic Valve Replacement/Transcather Aortic Valve Implantation, Quality and Outcomes, Valvular Heart Disease, Treatment, Catheter-Based Coronary and Valvular Interventions
- 65 results
- 12 result after checking boxes “2021” and “2020”
Google Scholar:
- Search words: endocarditis, aortic valve, TAVR, SAVR, low risk, aortic stenosis, aortic valve, surgery, transcatheter aortic valve, transcatheter aortic valve implantation, Aortic Valve Replacement/Transcather Aortic Valve Implantation, Quality and Outcomes, Valvular Heart Disease, Treatment, Catheter-Based Coronary and Valvular Interventions
- Filter “Since 2017” applied
- 132 Results
There is a significant amount of data collected on this topic since it has been up for debate by many surgeons. I am going to include the most recent articles as well as ones covering Intermediate Risk for Perioperative Cardiac Complications patient sample representative of my patient (PMH of DM & HTN).
Article #1
| Name | Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients RCT |
| Citation | Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients Martin B. Leon, M.D., Craig R. Smith, M.D., Michael J. Mack, M.D., Raj R. Makkar, M.D., Lars G. Svensson, M.D., Ph.D., Susheel K. Kodali, M.D., Vinod H. Thourani, M.D., E. Murat Tuzcu, M.D., D. Craig Miller, M.D., Howard C. Herrmann, M.D., Darshan Doshi, M.D., David J. Cohen, M.D., et al., for the PARTNER 2 Investigators* N Engl J Med 2016; 374:1609-1620. DOI: 10.1056/NEJMoa1514616 |
| Type | RCT |
| Abstract | BACKGROUND Previous trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic- valve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODS We randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTS The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P=0.001 for noninferiority). At 2 years, the Kaplan–Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P=0.25). In the transfemoral- access cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P=0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. |
| Key Points | In intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. |
| Why I chose it | This is a Randomized Controlled trial with a strong design that has a significant N number (2032 patients). This study informed the currently ongoing PARTNER 2A clinical trial that should be completed in Dec 2024. Since the trial is not over yet, I could not reliably include it’s currently raw data in my research. |
| Hyperlink &PDF | https://www.nejm.org/doi/full/10.1056/NEJMoa1514616 |
Article #2
| Name | Endocarditis in Patients with Aortic Valve Prosthesis: Comparison between Surgical and Transcatheter Prosthesis |
| Citation | De Palo M, Scicchitano P, Malvindi PG, Paparella D. Endocarditis in Patients with Aortic Valve Prosthesis: Comparison between Surgical and Transcatheter Prosthesis. Antibiotics (Basel). 2021;10(1):50. Published 2021 Jan 6. doi:10.3390/antibiotics10010050 |
| Type | Meta-analysis |
| Abstract | The interventional treatment of aortic stenosis is currently based on transcatheter aortic valve implantation/replacement (TAVI/TAVR) and surgical aortic valve replacement (SAVR). Prosthetic valve infective endocarditis (PVE) is the most worrisome complication after valve replacement, as it still carries high mortality and morbidity rate. Studies have not highlighted the differences in the occurrence of PVE in SAVR as opposed to TAVR, but the reported incidence rates are widely uneven. Literature portrays different microbiological profiles for SAVR and TAVR PVE: Staphylococcus, Enterococcus, and Streptococcus are the pathogens that are more frequently involved with differences regarding the timing from the date of the intervention. Imaging by means of transesophageal echocardiography, and computed tomography (CT) Scan is essential in identifying vegetations, prosthesis dysfunction, dehiscence, periannular abscess, or aorto-ventricular discontinuity. In most cases, conservative medical treatment is not able to prevent fatal events and surgery represents the only viable option. The primary objectives of surgical treatment are radical debridement and the removal of infected tissues, the reconstruction of cardiac and aortic morphology, and the restoration of the aortic valve function. Different surgical options are discussed. Fast diagnosis, the adequacy of antibiotics treatment, and prompt interventions are essential in preventing the negative consequences of infective endocarditis (IE) |
| Key Points | Infective endocarditis on prosthetic valves still remain the most worrisome complication after both the SAVR and TAVR procedures. Published studies do not reveal whether either technique is riskier in determining infective endocarditis. Indeed, IE after TAVR or SAVR can dramatically affect the survival rate of patients, even despite adequate antibiotic therapies and/or further surgical, re-do interventions. Adequacy in antibiotic prophylaxis before the two interventions, correct selection of the candidates, fast diagnosis, and prompt interventions might be considered to be the cornerstone in preventing the negative consequences of IE. |
| Why I chose it | This is a most up to date meta-analysis comparing endocarditis incidence rates between TAVR and SAVR patients. |
| Hyperlink &PDF | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7825452/ |
Article #3
| Name | Risk‐Adjusted Comparison of In‐Hospital Outcomes of Transcatheter and Surgical Aortic Valve Replacement |
| Citation | Stachon P, Kaier K, Zirlik A, et al. Risk-Adjusted Comparison of In-Hospital Outcomes of Transcatheter and Surgical Aortic Valve Replacement. J Am Heart Assoc. 2019;8(7):e011504. doi:10.1161/JAHA.118.011504 |
| Type | Retrospective Analysis 2020 |
| Abstract | Background Transfemoral transcatheter aortic valve replacement (TF‐TAVR) is recommended for patients suffering from aortic valve stenosis at increased operative risk. Beyond that, patients with different comorbidities could benefit from TF‐TAVR. The present study compares real‐world in‐hospital outcomes of surgical aortic valve replacement and TF‐TAVR. Methods and Results For all 33 789 isolated TF‐TAVR and surgical aortic valve replacement procedures performed in Germany in 2014 and 2015, comorbidities and in‐hospital outcomes were identified by International Classification of Diseases (ICD)‐ and OPS (Operation and procedure key)‐codes. Patients undergoing TF‐TAVR were older and at increased estimated risk. Outcomes were risk‐adjusted to allow comparison. TF‐TAVR was associated with a lower risk for acute kidney injuries (odds ratio [OR] 0.62, P<0.001), for bleeding (OR 0.17, P<0.001), and for prolonged mechanical ventilation (>48 hours, OR 0.21, P<0.001). Risk for stroke was similar (OR 1.07, P=0.558). As expected, the risk for pacemaker implantations was higher after TF‐TAVR (OR 4.61, P<0.001). In all patients, none of the treatment strategies had a clear advantage on the risk for in‐hospital mortality (OR 0.83, P=0.068). However, in patients aged >80 years and at high operative risk undergoing TF‐TAVR in‐hospital mortality was lower (TF‐TAVR versus surgical aortic valve replacement 80–84, OR 0.55; P=0.002; ≥85 years, OR 0.42, P=0.006; EuroSCORE (European System for Cardiac Operative Risk Evaluation) >9: OR 0.62, P=0.001). TF‐TAVR was superior in patients with renal failure and in NYHA (New York Heart Association)‐Class III/IV. Other risk groups were not found to be factors favoring a treatment strategy. Conclusions The present study indicates a superiority of TF‐TAVR in clinical practice for patients at increased operative risk, aged >80 years, in NYHA‐Class III/IV, and with renal failure. |
| Key Points | Study analyzed >33 000 real‐world aortic valve replacements and identified subgroups which benefit from transfemoral transcatheter aortic valve replacement.In all subgroups, patients undergoing transfemoral transcatheter aortic valve replacement had lower adjusted risk for acute kidney injuries, lower risk of bleeding, and lower risk for prolonged mechanical ventilation compared with patients undergoing surgical aortic valve replacement.The risk for in‐hospital mortality was lower in patients at increased operative risk, aged >80 years, in patients with advanced kidney failure, and in highly symptomatic patients. |
| Why I chose it | Choosing a Retrospective Analysis allowed for a massive N number of 33 789 patients. Since most patients undergoing TAVR were older and/or had more comorbidities, outcomes were risk adjusted to allow comparison. |
| Hyperlink &PDF | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6509703/ |
Article #4
| Name | Surgical versus trans-catheter aortic valve replacement (SAVR vs TAVR) in patients with aortic stenosis |
| Citation | Ziv-Baran T, Zelman RB, Dombrowski P, Schaub AE, Mohr R, Loberman D. Surgical versus trans-catheter aortic valve replacement (SAVR vs TAVR) in patients with aortic stenosis: Experience in a community hospital. Medicine (Baltimore). 2019;98(45):e17915. doi:10.1097/MD.0000000000017915 |
| Type | Historical cohort study |
| Abstract | Trans-catheter aortic valve replacement (TAVR) has become an alternative to surgical aortic valve replacement (SAVR) in high and intermediate risk patients with aortic stenosis. TAVR programs are spreading from large referral centers and being established in community based institutions. The purpose of this study was to compare the outcomes of TAVR to those of SAVR in a community hospital. A historical cohort study of patients with aortic stenosis and pre-post procedure echocardiography data who underwent SAVR or TAVR in Cape Cod Hospital between January 2014 and December 2016. Patient characteristics and procedure outcomes were compared between the two procedures. The study included 230 patients, of them 111 underwent SAVR and 119 underwent TAVR. None of the patients died during the 30 days after the procedure. TAVR patients had higher rates of postoperative mild+ aortic regurgitation (AR) (29.4% vs 12.6%, P = .002), postoperative atrial ventricular blocks (11.8% vs 0.9%, P = .001), and more often need an implantation of pacemaker (16.8% vs 0.9%, P < .001). Postoperative mean gradient of SAVR patients was higher (median 14 vs 11 mm Hg, P = .001) and atrial fibrillation postoperatively was more frequent (18.9% vs 2.5%, P < .001). Length of stay after procedure was shorter in TAVR patients (median 2 vs 4 days, P < .001). After controlling for confounders, the use of TAVR was associated with an increased risk for postoperative pacemaker implantation (OR = 16.3, 95%CI 1.91–138.7, P = .011), lower mean gradient (−4.327, 95%CI −7.68 to −0.98, P = .011), and lower risk for atrial fibrillation (OR = 0.11, 95%CI 0.03–0.38, P = .001), but not with postoperative AR (OR = 0.84, 95%CI 0.22–3.13, P = .789). |
| Key Points | In conclusion, short-term mortality was not reported in SAVR or TAVR patients. However, TAVR was associated with an increased risk for postoperative pacemaker implantation but with a lower risk for atrial fibrillation. Aortic valves implanted through a trans-catheter approach are also associated with a better hemodynamic performance. |
| Why I chose it | This is another recent study tracking the outcomes for intermediate surgical risk patients. I chose it because it was conducted in a community hospital located within the United States. The study was adjusted for confounders and bias. |
| Hyperlink &PDF | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6855625/ |
Article #5
| Name | Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk |
| Citation | Virtanen MPO, Eskola M, Jalava MP, et al. Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk [published correction appears in JAMA Netw Open. 2019 Jul 3;2(7):e198352]. JAMA Netw Open. 2019;2(6):e195742. Published 2019 Jun 5. doi:10.1001/jamanetworkopen.2019.5742 |
| Type | Retrospective Analysis |
| Abstract | Importance Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce. Objective To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS. Design, Setting, and Participants This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts. Exposures Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization. Main Outcomes and Measures The primary outcomes were 30-day and 3-year survival. Results Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not. Conclusions and Relevance Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients. |
| Key Points | Question Does transcatheter aortic valve replacement achieve similar results compared with surgical aortic valve replacement in patients at low operative risk with severe aortic stenosis? Findings In this comparative effectiveness cohort study of 2841 low-risk patients with aortic stenosis from Finalnd, propensity score–matching analysis showed similar 30-day and 3-year survival after transcatheter aortic valve replacement and surgical aortic valve replacement. Meaning Patients with severe aortic stenosis at low operative risk may be offered transcatheter aortic valve replacement instead of surgical aortic valve replacement. |
| Why I chose it | This is a retrospective analysis from 2019 comparing the outcomes of TAVR and SAVR tracking 30-day and 3-year survival |
| Hyperlink &PDF | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6575142/ |
Summary of the Evidence:
| Author (Date) | Level of Evidence | Sample/Setting (# of subjects/ studies, cohort definition etc. ) | Outcome(s) studied | Key Findings | Limitations and Biases |
| Martin B.Leon., et al, 2016 | RCT | Authors randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. | Death Disabling stroke Vascular complications Acute Kidney Injury New onset a-fib Duration of stay in the ICU | In intermediate- risk patients with severe symptomatic aortic stenosis, surgical and transcatheter valve replacement were similar with respect to the primary end point of death or disabling stroke for up to 2 years and resulted in a similar degree of lessening of cardiac symptoms | First, further technological advances may favorably infuence the outcomes with TAVR in the future, and the SAPIEN XT valve that was used in this trial has already been replaced by the SAPIEN 3 valve system Second, in this trial, multislice computed tomography was not used consistently to assess aortic annulus dimensions for appropriate valve sizing. Also, the recent finding of subclinical valve- leaflet thrombosis with the use of high-resolution imaging techniques was not systematically evaluated in the current trial. Finally, long-term assessments of the durability of bioprosthetic transcatheter valves (i.e., through 10 years) remain a limitation, although 5-year echocardiographic evaluations from the earlier PARTNER trials indicate no evidence of important premature or accelerated structural valve deterioration |
| Michaela De Palo et. Al., 2021 | Meta-Analysis | Authors analyzed data from: Moriyama et al., Finn Valve registry (retrospective, 2019) – N=4333 Luehr et al., observational study, 2019 – N=103Fauschier et al., French registry, 2020, retrospective – N=60,253US Nationwide remissions database, 2018, N=66,077Butt et al., 2019, Nationwide observational cohort study, N=3777Luehr et al., 2019, retrospective, observational – N=103Summers et al., 2019, Cohort study PARTNER RCTs and registries, N=1257 | Rates of EndocarditisIn-hospital mortalityFollow-up mortality1-year mortalityDeep Sternal Wound Infection/vascular access wound infection | Published studies do not reveal whether either technique is riskier in determining infective endocarditis. Indeed, IE after TAVR or SAVR can dramatically affect the survival rate of patients, even despite adequate antibiotic therapies and/or further surgical, re-do interventions. Adequacy in antibiotic prophylaxis before the two interventions, correct selection of the candidates, fast diagnosis, and prompt interventions might be considered to be the cornerstone in preventing the negative consequences of IE. | Authors declare no conflict of interests Meta analysis allows for inclusion of vast amount of data at the expense of controlling for various confounders. However, study still did not reveal whether either technique is riskier in determining infective endocarditis. |
| Peter Stachon et al., 2019 | Retrospective analysis | For all 33 789 isolated TF-TAVR and surgical aortic valve replacement procedures performed in Germany in 2014 and 2015, comorbidities and in-hospital outcomes were identified by International Classification of Diseases (ICD)- and OPS (Operation and procedure key)-codes. Patients undergoing TF-TAVR were older and at increased estimated risk. Outcomes were risk-adjusted to allow comparison. | Acute Kidney InjuriesStrokeBleedingProlonged mechanical ventilationPacemaker implantationIn-hospital mortality risk | TF-TAVR was associated with a lower risk for acute kidney injuries (odds ratio [OR] 0.62, P<0.001), for bleeding (OR 0.17, P<0.001), and for prolonged mechanical ventilation (>48 hours, OR 0.21, P<0.001). Risk for stroke was similar (OR 1.07, P=0.558). As expected, the risk for pacemaker implantations was higher after TF-TAVR (OR 4.61, P<0.001). In all patients, none of the treatment strategies had a clear advantage on the risk for in-hospital mortality (OR 0.83, P=0.068). However, in patients aged >80 years and at high operative risk undergoing TF-TAVR in-hospital mortality was lower (TF- TAVR versus surgical aortic valve replacement 80–84, OR 0.55; P=0.002; ≥85 years, OR 0.42, P=0.006; EuroSCORE (European System for Cardiac Operative Risk Evaluation) >9: OR 0.62, P=0.001). TF-TAVR was superior in patients with renal failure and in NYHA (New York Heart Association)-Class III/IV. | First of all, the chosen comparison (SAVR versus TF-TAVR) assumes that the transfemoral approach is anatomically feasible. Furthermore, apart from the limitations typically associated with retrospective studies, the analysis has several specific limitations: It is based on administrative data, designed to report diagnoses and procedures, and intended to trigger reimbursement. Hence, while the competing interests of hospitals and sickness funds should ensure a high level of data reliability and quality, coding errors cannot be ruled out with certainty, in particular with codes that do not impact reimbursement (such as previous stroke, new atrioventricular block or left bundle branch block, anticoagulation therapy). Moreover, the administrative data set lacks relevant clinical information (such as echocardiographic findings or anatomical characteristics), preventing operative risk assess- ment and a better understanding of the underlying valvular pathomechanism. Therefore, only an approximation of the logistic EuroSCORE, in fact a conservative or ‘best-case scenario’ estimate, is applied. Furthermore, even the decision-making process within the different centers may differ substantially: most centers might have implemented a transfemoral-first approach as part of the decision process within the interdisciplinary “Heart Team”, and some centers might not even have a “Heart Team”. In addition, long-term follow up data are missing, as DESTATIS provides no longitudinal data or cross-links with other clinical or administrative data sets. Finally, this analysis relies on data from the German healthcare system and other countries’ experiences may differ. |
| Tomer Ziv-Baran et al., 2019 | Historical Cohort Study | This is a historical cohort study of patients who underwent SAVR or TAVR for aortic stenosis at Cape Cod Hospital (CCH) between January 2014 and December 2016. The TAVR program was established in CCH in June 2015. Patients who underwent SAVR between January 2014 and December 2016 and patients who underwent TAVR between June 2015 and December 2016 were compared. Patients without complete pre- and post-procedure trans-thoracic echo-cardiographs were excluded. | Overall mortality ratesPostoperative Ao regurgitationPost-op AV blocksPostoperative pacemaker implantation | None of the patients died during the 30 days after the procedure. TAVR patients had higher rates of postoperative mild+ aortic regurgitation (AR) (29.4% vs 12.6%, P = .002), postoperative atrial ventricular blocks (11.8% vs 0.9%, P = .001), and more often need an implantation of pacemaker (16.8% vs 0.9%, P < .001). Postoperative mean gradient of SAVR patients was higher (median 14 vs 11 mm Hg, P = .001) and atrial fibrillation postoperatively was more frequent (18.9% vs 2.5%, P < .001). Length of stay after procedure was shorter in TAVR patients (median 2 vs 4 days, P < .001). After controlling for confounders, the use of TAVR was associated with an increased risk for postoperative pacemaker implantation (OR = 16.3, 95%CI 1.91–138.7, P = .011), lower mean gradient (−4.327, 95%CI −7.68 to −0.98, P = .011), and lower risk for atrial fibrillation (OR = 0.11, 95%CI 0.03–0.38, P = .001), but not with postoperative AR (OR = 0.84, 95%CI 0.22–3.13, P = .789). In conclusion, short-term mortality was not reported in SAVR or TAVR patients. However, TAVR was associated with an increased risk for postoperative pacemaker implantation but with a lower risk for atrial fibrillation. Aortic valves implanted through a trans-catheter approach are also associated with a better hemodynamic performance | Pre-procedure patient characteristics were significantly different between groups: Patients treated with TAVR were older, more often female, more likely to have moderate or severe MR), had higher STS probability for mortality, smaller aortic valve area , and less likely to have prior PCI or CABG. SAVR patients had more often rapid arrhythmia, atrial fibrillation or flutter, and had higher postoperative mean gradient |
| Marko P.O. Virtanen et al., 2019 | Retrospective Analysis | Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P = .12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P = .45) | 30 day survival3 year survivalStrokeBlood transfusionCoronary Artery OcclusionAortic Dissection/ruptureA-fibPostoperative LOSNeed for repeated valve replacement | Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients | The main limitation of this study is its retrospective nature. Second, the definition of low risk was based on a cutoff value of 3% for operative mortality as estimated by the STS-PROM scoring system and by excluding patients deemed at increased risk because of significant comorbidities. Despite these inclusion criteria, it is possible that some patients included or excluded from this analysis were incorrectly classified. Third, comparative analysis of the study cohorts was based on propensity score matching, and its results are potentially biased by unmeasured confounders despite well-balanced covariates. Fourth, the relatively small size of the matched study cohorts may affect the reliability of these results. Fifth, the limited length of follow-up of patients with low operative risk prevented more conclusive results on the durability of TAVR in this patient population |
Conclusion(s):
1 – In intermediate- risk patients with severe symptomatic aortic stenosis, surgical and transcatheter valve replacement were similar with respect to the primary end point of death or disabling stroke for up to 2 years and resulted in a similar degree of lessening of cardiac symptoms
2 – Endocarditis: Published studies do not reveal whether either technique is riskier in determining infective endocarditis.
3 – Data show that TF‐TAVR is associated with a decreased risk for in‐hospital mortality in patients with an age >80 years, at high operative risk, with advanced renal failure, and in NYHA Class III or IV. Outcomes for SAVR or TF‐TAVR in the remaining subgroups were comparable.
4 – In conclusion, short-term mortality was not reported in SAVR or TAVR patients. However, TAVR was associated with an increased risk for postoperative pacemaker implantation but with a lower risk for atrial fibrillation. Aortic valves implanted through a trans-catheter approach are also associated with a better hemodynamic performance.
5 – Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients
Even though up to date studies show very promising results, awaiting data from conclusion of partner-2 and from Partner 3 that will hopefully bring some more clarity as per whether TAVR should be made into a default procedure for intermediate surgical risk patients with Aortic Stenosis.
Clinical Bottom Line:
– Weight of the evidence –
1 – RCT allows for the most precision to the study. Thus far the PARTNER 2A trial assisted by my study #1showed that TAVR is noninferior to SAVR for the primary endpoint at 2 years for the treatment of severe aortic stenosis in intermediate-risk patients (STS-PROM 4-8%; median 5.8%). Since the study is still in progress (estimated completion date: Nov 2024), Further long-term data from the S3 cohort of the PARTNER 2 trial also are awaited.
2 – Meta analysis allows for inclusion of vast amount of data at the expense of controlling for various confounders. However, study still did not reveal whether either technique is riskier in determining infective endocarditis.
3 – Retrospective Analysis is an appropriate study design for tracking outcomes. However, limitations typically associated with retrospective studies are that they are based on administrative data, designed to report diagnoses and procedures, and intended to trigger reimbursement.
4 – Historical Cohort study is also appropriate when tracking outcomes, especially long term. In this case though, a discrepancy between pre-procedure patient characteristics is the study’s main weakness.
5 – Retrospective Analysis – shares some of the weaknesses of historical Cohort study and the study #3 mentioned above
– Magnitude of any effects –
The publication of the low-risk TAVR trials represents a tremendous advance in the management of aortic stenosis and speaks to the significant progress made in the development of THV technology, cardiovascular imaging, and operator technique. It is likely that the volume of low-risk patients being evaluated by heart teams will increase exponentially, and many informed patients with aortic valve disease will come seeking percutaneous options.
However, Significant unknowns remain regarding the outcomes of TAVR in patients with bicuspid AS, patients adverse asymmetric annular calcification, and those with significant co-morbid multivessel CAD1.
– Clinical significance (not just statistical significance)
While more and more patients are going to inquire for a transthoracic approach to a needed intervention, a decision on a type of procedure still needs to be individually catered to each patient using shared decision making informed by patient’s risk factors, pre and peri-operative surgical risks and overall treatment goals.
– Any other considerations important in weighing this evidence to guide practice –
A vast amount of data is available where different authors try to reliably answer a question whether TAVR can produce same or, hopefully, better outcomes than an open-heart surgery that many patients have reservations about.
All studies have their limitations, therefore, large N number Randomized Controlled Trials, preferably performed in the United States, are needed. Luckily, an ongoing PARTNER2 study is in process, which will hopefully bring clarity in 2024.
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